Prepared by Salwa Ibrahim Supervised by Dr Ola Anabtawi

MEDINA

(Mediterranean Dietary Intervention

study in Non-alcoholic fatty liver disease)

1

bull INTRODUCTION

bull METHODS

bull RESULT

bull DISCUSSION

bull Recommendation

2

3

Non-alcoholic fatty liver disease (NAFLD) and its progressive form non-alcoholic steatohepatitis (NASH) are among the most prevalent of liver diseases worldwide

Approximately 20 to 30 of the adult population has NAFLD making it the most common liver disease in developed countries

The incidence is as high as 50ndash85 in people with pre-diabetes and diabetes

Diet is a modifiable risk factor that can potentially be targetedin both the prevention and treatment of NAFLD

4

Hepatocellular carcinoma

Lead to cirrhosis and its

complication include

portal hypertensive

bleeding

Hepatic decompensation

NAFLD

5

1bull demonstrated a significant improvement in insulin sensitivity and

hepatic steatosis with the MedDiet compared to the low fat diet group

2

bull aims to replicate the findings of Ryan et alrsquos pilot study in alarger cohort of participants with NAFLD in a more translatable environment and with assessment of sustainability

3bull aims to investigate the effects of adhering to the MedDiet as compared

to a low fat diet

Pilot data to support the shift from current dietary therapy to a novel MedDietintervention of patients with NAFLD has been published by Ryan et al in NAFLD patients This study

6

lower incidence of chronic disease

including CVD

Obesity

Dementia

Some cancers

Overall mortalityAnd keep you young nourish your body

7

12 week multi-centre

parallel randomisedcontrolled trial of a Med Diet versus a Low Fat Diet (LFD)

8

Are Non-English speaking

Consume on average gt140 gweek of alcohol (men and women)

Are taking the following medicationsimmunosuppressants amiodarone andor perhexiline

Have a HbA1c score exceeding 8

Have clinically relevant pulmonary gastro-intestinal renal metabolic hematological neurological

Are women who are pregnant

Have psychosocial or gastrointestinal (eg malabsorptiveconditions eg coeliac)

Age gt18 years

(BMI) between 20 and 399 kgm2

diagnosis of NAFLD determined

by routine ultrasound or biopsy

insulin resistance based on a HOMA IR score of gt2 and at least one elevated

serum ALT level (gt20 UL female gt30 UL male) during the past 6 months

9

10

The intervention is based on

11

LOW FAT DIETMEDITERRANEAN FOOD PYRAMID VS

12

All participants will be provided with written resources specifically designed to explain the and how it can be successfully followed and adhered to These resourcestMedDie

include

A food pyramid

healthy eating guidelines and tips

meal plans

recipes in the form of The Mediterranean Diet

a shopping list label reading

Participants will also be supplied with extra virgin olive oil

nuts

canned legumes

Fish

Breakfast is also provided on the day of all face to face appointments

13

Low fat diet

The LFD group will follow the same structure as theMedDiet arm with three face to face consultations atbaseline 6 weeks (mid intervention) and 12 weeks (endof intervention)

There will also be the same number of phone call follow ups at weeks 2 4 and 9

Participants will also be given a supermarket gift voucher to purchase some of the suggested food items

Breakfast is also provided on the day of all face to faceappointments

14

patients in the MedDiet

had significant improvements in insulin sensitivity as determinedby a 3-hour hyperinsulinaemic-euglycaemic clamp

significant reduction (39 ) in hepatic steatosis

low fat Diet

no significant improvement in insulin sensitivity and only a 7 reduction of hepatic steatosis with the low fat high carbohydrate diet

The changes observed in the intervention group were without a significantreduction in weight

15

The MedDiet has positive effects on insulin sensitivity which has been attributed to

the high content of bio-active phytochemicals with a range of antioxidant and anti-inflammatory activity

The MedDiet is characterised by a specific fatty acid profile low in saturated fat (7ndash8 of total energy) and high in monounsaturated fat(20 of total energy)

16

Although environmental influences such as diet have awell-established association with disease it is important to acknowledge that the interplay of genetics and environment are a widely accepted influence in disease outcomes

Currently there are no safe or effective proven therapiesfor the treatment of patients with NAFLD or NASH While diet and lifestyle changes focussing on achievingweight loss are the accepted recommendations for this patientGroupEnjoy your food eat whatrsquos good for you in moderation and remember the words of

ldquoLet food be the medicine and medicine be the foodrdquo

17

controlled trial of randomisedA ) 2016J( AmandaStuart KElena Sa Mediterranean Dietary Intervention for Adults with Non Alcoholic Fatty Liver Disease (MEDINA) study

3-0426-016-12876s118610)pp 14(16protocol

httpwwwdietplan-101commediterranean-diet-meal-planning-things-to-keep-in-mind

bull INTRODUCTION

bull METHODS

bull RESULT

bull DISCUSSION

bull Recommendation

2

3

Non-alcoholic fatty liver disease (NAFLD) and its progressive form non-alcoholic steatohepatitis (NASH) are among the most prevalent of liver diseases worldwide

Approximately 20 to 30 of the adult population has NAFLD making it the most common liver disease in developed countries

The incidence is as high as 50ndash85 in people with pre-diabetes and diabetes

Diet is a modifiable risk factor that can potentially be targetedin both the prevention and treatment of NAFLD

4

Hepatocellular carcinoma

Lead to cirrhosis and its

complication include

portal hypertensive

bleeding

Hepatic decompensation

NAFLD

5

1bull demonstrated a significant improvement in insulin sensitivity and

hepatic steatosis with the MedDiet compared to the low fat diet group

2

bull aims to replicate the findings of Ryan et alrsquos pilot study in alarger cohort of participants with NAFLD in a more translatable environment and with assessment of sustainability

3bull aims to investigate the effects of adhering to the MedDiet as compared

to a low fat diet

Pilot data to support the shift from current dietary therapy to a novel MedDietintervention of patients with NAFLD has been published by Ryan et al in NAFLD patients This study

6

lower incidence of chronic disease

including CVD

Obesity

Dementia

Some cancers

Overall mortalityAnd keep you young nourish your body

7

12 week multi-centre

parallel randomisedcontrolled trial of a Med Diet versus a Low Fat Diet (LFD)

8

Are Non-English speaking

Consume on average gt140 gweek of alcohol (men and women)

Are taking the following medicationsimmunosuppressants amiodarone andor perhexiline

Have a HbA1c score exceeding 8

Have clinically relevant pulmonary gastro-intestinal renal metabolic hematological neurological

Are women who are pregnant

Have psychosocial or gastrointestinal (eg malabsorptiveconditions eg coeliac)

Age gt18 years

(BMI) between 20 and 399 kgm2

diagnosis of NAFLD determined

by routine ultrasound or biopsy

insulin resistance based on a HOMA IR score of gt2 and at least one elevated

serum ALT level (gt20 UL female gt30 UL male) during the past 6 months

9

10

The intervention is based on

11

LOW FAT DIETMEDITERRANEAN FOOD PYRAMID VS

12

All participants will be provided with written resources specifically designed to explain the and how it can be successfully followed and adhered to These resourcestMedDie

include

A food pyramid

healthy eating guidelines and tips

meal plans

recipes in the form of The Mediterranean Diet

a shopping list label reading

Participants will also be supplied with extra virgin olive oil

nuts

canned legumes

Fish

Breakfast is also provided on the day of all face to face appointments

13

Low fat diet

The LFD group will follow the same structure as theMedDiet arm with three face to face consultations atbaseline 6 weeks (mid intervention) and 12 weeks (endof intervention)

There will also be the same number of phone call follow ups at weeks 2 4 and 9

Participants will also be given a supermarket gift voucher to purchase some of the suggested food items

Breakfast is also provided on the day of all face to faceappointments

14

patients in the MedDiet

had significant improvements in insulin sensitivity as determinedby a 3-hour hyperinsulinaemic-euglycaemic clamp

significant reduction (39 ) in hepatic steatosis

low fat Diet

no significant improvement in insulin sensitivity and only a 7 reduction of hepatic steatosis with the low fat high carbohydrate diet

The changes observed in the intervention group were without a significantreduction in weight

15

The MedDiet has positive effects on insulin sensitivity which has been attributed to

the high content of bio-active phytochemicals with a range of antioxidant and anti-inflammatory activity

The MedDiet is characterised by a specific fatty acid profile low in saturated fat (7ndash8 of total energy) and high in monounsaturated fat(20 of total energy)

16

Although environmental influences such as diet have awell-established association with disease it is important to acknowledge that the interplay of genetics and environment are a widely accepted influence in disease outcomes

Currently there are no safe or effective proven therapiesfor the treatment of patients with NAFLD or NASH While diet and lifestyle changes focussing on achievingweight loss are the accepted recommendations for this patientGroupEnjoy your food eat whatrsquos good for you in moderation and remember the words of

ldquoLet food be the medicine and medicine be the foodrdquo

17

controlled trial of randomisedA ) 2016J( AmandaStuart KElena Sa Mediterranean Dietary Intervention for Adults with Non Alcoholic Fatty Liver Disease (MEDINA) study

3-0426-016-12876s118610)pp 14(16protocol

httpwwwdietplan-101commediterranean-diet-meal-planning-things-to-keep-in-mind

3

Non-alcoholic fatty liver disease (NAFLD) and its progressive form non-alcoholic steatohepatitis (NASH) are among the most prevalent of liver diseases worldwide

Approximately 20 to 30 of the adult population has NAFLD making it the most common liver disease in developed countries

The incidence is as high as 50ndash85 in people with pre-diabetes and diabetes

Diet is a modifiable risk factor that can potentially be targetedin both the prevention and treatment of NAFLD

4

Hepatocellular carcinoma

Lead to cirrhosis and its

complication include

portal hypertensive

bleeding

Hepatic decompensation

NAFLD

5

1bull demonstrated a significant improvement in insulin sensitivity and

hepatic steatosis with the MedDiet compared to the low fat diet group

2

bull aims to replicate the findings of Ryan et alrsquos pilot study in alarger cohort of participants with NAFLD in a more translatable environment and with assessment of sustainability

3bull aims to investigate the effects of adhering to the MedDiet as compared

to a low fat diet

Pilot data to support the shift from current dietary therapy to a novel MedDietintervention of patients with NAFLD has been published by Ryan et al in NAFLD patients This study

6

lower incidence of chronic disease

including CVD

Obesity

Dementia

Some cancers

Overall mortalityAnd keep you young nourish your body

7

12 week multi-centre

parallel randomisedcontrolled trial of a Med Diet versus a Low Fat Diet (LFD)

8

Are Non-English speaking

Consume on average gt140 gweek of alcohol (men and women)

Are taking the following medicationsimmunosuppressants amiodarone andor perhexiline

Have a HbA1c score exceeding 8

Have clinically relevant pulmonary gastro-intestinal renal metabolic hematological neurological

Are women who are pregnant

Have psychosocial or gastrointestinal (eg malabsorptiveconditions eg coeliac)

Age gt18 years

(BMI) between 20 and 399 kgm2

diagnosis of NAFLD determined

by routine ultrasound or biopsy

insulin resistance based on a HOMA IR score of gt2 and at least one elevated

serum ALT level (gt20 UL female gt30 UL male) during the past 6 months

9

10

The intervention is based on

11

LOW FAT DIETMEDITERRANEAN FOOD PYRAMID VS

12

All participants will be provided with written resources specifically designed to explain the and how it can be successfully followed and adhered to These resourcestMedDie

include

A food pyramid

healthy eating guidelines and tips

meal plans

recipes in the form of The Mediterranean Diet

a shopping list label reading

Participants will also be supplied with extra virgin olive oil

nuts

canned legumes

Fish

Breakfast is also provided on the day of all face to face appointments

13

Low fat diet

The LFD group will follow the same structure as theMedDiet arm with three face to face consultations atbaseline 6 weeks (mid intervention) and 12 weeks (endof intervention)

There will also be the same number of phone call follow ups at weeks 2 4 and 9

Participants will also be given a supermarket gift voucher to purchase some of the suggested food items

Breakfast is also provided on the day of all face to faceappointments

14

patients in the MedDiet

had significant improvements in insulin sensitivity as determinedby a 3-hour hyperinsulinaemic-euglycaemic clamp

significant reduction (39 ) in hepatic steatosis

low fat Diet

no significant improvement in insulin sensitivity and only a 7 reduction of hepatic steatosis with the low fat high carbohydrate diet

The changes observed in the intervention group were without a significantreduction in weight

15

The MedDiet has positive effects on insulin sensitivity which has been attributed to

the high content of bio-active phytochemicals with a range of antioxidant and anti-inflammatory activity

The MedDiet is characterised by a specific fatty acid profile low in saturated fat (7ndash8 of total energy) and high in monounsaturated fat(20 of total energy)

16

Although environmental influences such as diet have awell-established association with disease it is important to acknowledge that the interplay of genetics and environment are a widely accepted influence in disease outcomes

Currently there are no safe or effective proven therapiesfor the treatment of patients with NAFLD or NASH While diet and lifestyle changes focussing on achievingweight loss are the accepted recommendations for this patientGroupEnjoy your food eat whatrsquos good for you in moderation and remember the words of

ldquoLet food be the medicine and medicine be the foodrdquo

17

controlled trial of randomisedA ) 2016J( AmandaStuart KElena Sa Mediterranean Dietary Intervention for Adults with Non Alcoholic Fatty Liver Disease (MEDINA) study

3-0426-016-12876s118610)pp 14(16protocol

httpwwwdietplan-101commediterranean-diet-meal-planning-things-to-keep-in-mind

4

Hepatocellular carcinoma

Lead to cirrhosis and its

complication include

portal hypertensive

bleeding

Hepatic decompensation

NAFLD

5

1bull demonstrated a significant improvement in insulin sensitivity and

hepatic steatosis with the MedDiet compared to the low fat diet group

2

bull aims to replicate the findings of Ryan et alrsquos pilot study in alarger cohort of participants with NAFLD in a more translatable environment and with assessment of sustainability

3bull aims to investigate the effects of adhering to the MedDiet as compared

to a low fat diet

Pilot data to support the shift from current dietary therapy to a novel MedDietintervention of patients with NAFLD has been published by Ryan et al in NAFLD patients This study

6

lower incidence of chronic disease

including CVD

Obesity

Dementia

Some cancers

Overall mortalityAnd keep you young nourish your body

7

12 week multi-centre

parallel randomisedcontrolled trial of a Med Diet versus a Low Fat Diet (LFD)

8

Are Non-English speaking

Consume on average gt140 gweek of alcohol (men and women)

Are taking the following medicationsimmunosuppressants amiodarone andor perhexiline

Have a HbA1c score exceeding 8

Have clinically relevant pulmonary gastro-intestinal renal metabolic hematological neurological

Are women who are pregnant

Have psychosocial or gastrointestinal (eg malabsorptiveconditions eg coeliac)

Age gt18 years

(BMI) between 20 and 399 kgm2

diagnosis of NAFLD determined

by routine ultrasound or biopsy

insulin resistance based on a HOMA IR score of gt2 and at least one elevated

serum ALT level (gt20 UL female gt30 UL male) during the past 6 months

9

10

The intervention is based on

11

LOW FAT DIETMEDITERRANEAN FOOD PYRAMID VS

12

All participants will be provided with written resources specifically designed to explain the and how it can be successfully followed and adhered to These resourcestMedDie

include

A food pyramid

healthy eating guidelines and tips

meal plans

recipes in the form of The Mediterranean Diet

a shopping list label reading

Participants will also be supplied with extra virgin olive oil

nuts

canned legumes

Fish

Breakfast is also provided on the day of all face to face appointments

13

Low fat diet

The LFD group will follow the same structure as theMedDiet arm with three face to face consultations atbaseline 6 weeks (mid intervention) and 12 weeks (endof intervention)

There will also be the same number of phone call follow ups at weeks 2 4 and 9

Participants will also be given a supermarket gift voucher to purchase some of the suggested food items

Breakfast is also provided on the day of all face to faceappointments

14

patients in the MedDiet

had significant improvements in insulin sensitivity as determinedby a 3-hour hyperinsulinaemic-euglycaemic clamp

significant reduction (39 ) in hepatic steatosis

low fat Diet

no significant improvement in insulin sensitivity and only a 7 reduction of hepatic steatosis with the low fat high carbohydrate diet

The changes observed in the intervention group were without a significantreduction in weight

15

The MedDiet has positive effects on insulin sensitivity which has been attributed to

the high content of bio-active phytochemicals with a range of antioxidant and anti-inflammatory activity

The MedDiet is characterised by a specific fatty acid profile low in saturated fat (7ndash8 of total energy) and high in monounsaturated fat(20 of total energy)

16

Although environmental influences such as diet have awell-established association with disease it is important to acknowledge that the interplay of genetics and environment are a widely accepted influence in disease outcomes

Currently there are no safe or effective proven therapiesfor the treatment of patients with NAFLD or NASH While diet and lifestyle changes focussing on achievingweight loss are the accepted recommendations for this patientGroupEnjoy your food eat whatrsquos good for you in moderation and remember the words of

ldquoLet food be the medicine and medicine be the foodrdquo

17

controlled trial of randomisedA ) 2016J( AmandaStuart KElena Sa Mediterranean Dietary Intervention for Adults with Non Alcoholic Fatty Liver Disease (MEDINA) study

3-0426-016-12876s118610)pp 14(16protocol

httpwwwdietplan-101commediterranean-diet-meal-planning-things-to-keep-in-mind

5

1bull demonstrated a significant improvement in insulin sensitivity and

hepatic steatosis with the MedDiet compared to the low fat diet group

2

bull aims to replicate the findings of Ryan et alrsquos pilot study in alarger cohort of participants with NAFLD in a more translatable environment and with assessment of sustainability

3bull aims to investigate the effects of adhering to the MedDiet as compared

to a low fat diet

Pilot data to support the shift from current dietary therapy to a novel MedDietintervention of patients with NAFLD has been published by Ryan et al in NAFLD patients This study

6

lower incidence of chronic disease

including CVD

Obesity

Dementia

Some cancers

Overall mortalityAnd keep you young nourish your body

7

12 week multi-centre

parallel randomisedcontrolled trial of a Med Diet versus a Low Fat Diet (LFD)

8

Are Non-English speaking

Consume on average gt140 gweek of alcohol (men and women)

Are taking the following medicationsimmunosuppressants amiodarone andor perhexiline

Have a HbA1c score exceeding 8

Have clinically relevant pulmonary gastro-intestinal renal metabolic hematological neurological

Are women who are pregnant

Have psychosocial or gastrointestinal (eg malabsorptiveconditions eg coeliac)

Age gt18 years

(BMI) between 20 and 399 kgm2

diagnosis of NAFLD determined

by routine ultrasound or biopsy

insulin resistance based on a HOMA IR score of gt2 and at least one elevated

serum ALT level (gt20 UL female gt30 UL male) during the past 6 months

9

10

The intervention is based on

11

LOW FAT DIETMEDITERRANEAN FOOD PYRAMID VS

12

All participants will be provided with written resources specifically designed to explain the and how it can be successfully followed and adhered to These resourcestMedDie

include

A food pyramid

healthy eating guidelines and tips

meal plans

recipes in the form of The Mediterranean Diet

a shopping list label reading

Participants will also be supplied with extra virgin olive oil

nuts

canned legumes

Fish

Breakfast is also provided on the day of all face to face appointments

13

Low fat diet

The LFD group will follow the same structure as theMedDiet arm with three face to face consultations atbaseline 6 weeks (mid intervention) and 12 weeks (endof intervention)

There will also be the same number of phone call follow ups at weeks 2 4 and 9

Participants will also be given a supermarket gift voucher to purchase some of the suggested food items

Breakfast is also provided on the day of all face to faceappointments

14

patients in the MedDiet

had significant improvements in insulin sensitivity as determinedby a 3-hour hyperinsulinaemic-euglycaemic clamp

significant reduction (39 ) in hepatic steatosis

low fat Diet

no significant improvement in insulin sensitivity and only a 7 reduction of hepatic steatosis with the low fat high carbohydrate diet

The changes observed in the intervention group were without a significantreduction in weight

15

The MedDiet has positive effects on insulin sensitivity which has been attributed to

the high content of bio-active phytochemicals with a range of antioxidant and anti-inflammatory activity

The MedDiet is characterised by a specific fatty acid profile low in saturated fat (7ndash8 of total energy) and high in monounsaturated fat(20 of total energy)

16

Although environmental influences such as diet have awell-established association with disease it is important to acknowledge that the interplay of genetics and environment are a widely accepted influence in disease outcomes

Currently there are no safe or effective proven therapiesfor the treatment of patients with NAFLD or NASH While diet and lifestyle changes focussing on achievingweight loss are the accepted recommendations for this patientGroupEnjoy your food eat whatrsquos good for you in moderation and remember the words of

ldquoLet food be the medicine and medicine be the foodrdquo

17

controlled trial of randomisedA ) 2016J( AmandaStuart KElena Sa Mediterranean Dietary Intervention for Adults with Non Alcoholic Fatty Liver Disease (MEDINA) study

3-0426-016-12876s118610)pp 14(16protocol

httpwwwdietplan-101commediterranean-diet-meal-planning-things-to-keep-in-mind

6

lower incidence of chronic disease

including CVD

Obesity

Dementia

Some cancers

Overall mortalityAnd keep you young nourish your body

7

12 week multi-centre

parallel randomisedcontrolled trial of a Med Diet versus a Low Fat Diet (LFD)

8

Are Non-English speaking

Consume on average gt140 gweek of alcohol (men and women)

Are taking the following medicationsimmunosuppressants amiodarone andor perhexiline

Have a HbA1c score exceeding 8

Have clinically relevant pulmonary gastro-intestinal renal metabolic hematological neurological

Are women who are pregnant

Have psychosocial or gastrointestinal (eg malabsorptiveconditions eg coeliac)

Age gt18 years

(BMI) between 20 and 399 kgm2

diagnosis of NAFLD determined

by routine ultrasound or biopsy

insulin resistance based on a HOMA IR score of gt2 and at least one elevated

serum ALT level (gt20 UL female gt30 UL male) during the past 6 months

9

10

The intervention is based on

11

LOW FAT DIETMEDITERRANEAN FOOD PYRAMID VS

12

All participants will be provided with written resources specifically designed to explain the and how it can be successfully followed and adhered to These resourcestMedDie

include

A food pyramid

healthy eating guidelines and tips

meal plans

recipes in the form of The Mediterranean Diet

a shopping list label reading

Participants will also be supplied with extra virgin olive oil

nuts

canned legumes

Fish

Breakfast is also provided on the day of all face to face appointments

13

Low fat diet

The LFD group will follow the same structure as theMedDiet arm with three face to face consultations atbaseline 6 weeks (mid intervention) and 12 weeks (endof intervention)

There will also be the same number of phone call follow ups at weeks 2 4 and 9

Participants will also be given a supermarket gift voucher to purchase some of the suggested food items

Breakfast is also provided on the day of all face to faceappointments

14

patients in the MedDiet

had significant improvements in insulin sensitivity as determinedby a 3-hour hyperinsulinaemic-euglycaemic clamp

significant reduction (39 ) in hepatic steatosis

low fat Diet

no significant improvement in insulin sensitivity and only a 7 reduction of hepatic steatosis with the low fat high carbohydrate diet

The changes observed in the intervention group were without a significantreduction in weight

15

The MedDiet has positive effects on insulin sensitivity which has been attributed to

the high content of bio-active phytochemicals with a range of antioxidant and anti-inflammatory activity

The MedDiet is characterised by a specific fatty acid profile low in saturated fat (7ndash8 of total energy) and high in monounsaturated fat(20 of total energy)

16

Although environmental influences such as diet have awell-established association with disease it is important to acknowledge that the interplay of genetics and environment are a widely accepted influence in disease outcomes

Currently there are no safe or effective proven therapiesfor the treatment of patients with NAFLD or NASH While diet and lifestyle changes focussing on achievingweight loss are the accepted recommendations for this patientGroupEnjoy your food eat whatrsquos good for you in moderation and remember the words of

ldquoLet food be the medicine and medicine be the foodrdquo

17

controlled trial of randomisedA ) 2016J( AmandaStuart KElena Sa Mediterranean Dietary Intervention for Adults with Non Alcoholic Fatty Liver Disease (MEDINA) study

3-0426-016-12876s118610)pp 14(16protocol

httpwwwdietplan-101commediterranean-diet-meal-planning-things-to-keep-in-mind

7

12 week multi-centre

parallel randomisedcontrolled trial of a Med Diet versus a Low Fat Diet (LFD)

8

Are Non-English speaking

Consume on average gt140 gweek of alcohol (men and women)

Are taking the following medicationsimmunosuppressants amiodarone andor perhexiline

Have a HbA1c score exceeding 8

Have clinically relevant pulmonary gastro-intestinal renal metabolic hematological neurological

Are women who are pregnant

Have psychosocial or gastrointestinal (eg malabsorptiveconditions eg coeliac)

Age gt18 years

(BMI) between 20 and 399 kgm2

diagnosis of NAFLD determined

by routine ultrasound or biopsy

insulin resistance based on a HOMA IR score of gt2 and at least one elevated

serum ALT level (gt20 UL female gt30 UL male) during the past 6 months

9

10

The intervention is based on

11

LOW FAT DIETMEDITERRANEAN FOOD PYRAMID VS

12

All participants will be provided with written resources specifically designed to explain the and how it can be successfully followed and adhered to These resourcestMedDie

include

A food pyramid

healthy eating guidelines and tips

meal plans

recipes in the form of The Mediterranean Diet

a shopping list label reading

Participants will also be supplied with extra virgin olive oil

nuts

canned legumes

Fish

Breakfast is also provided on the day of all face to face appointments

13

Low fat diet

The LFD group will follow the same structure as theMedDiet arm with three face to face consultations atbaseline 6 weeks (mid intervention) and 12 weeks (endof intervention)

There will also be the same number of phone call follow ups at weeks 2 4 and 9

Participants will also be given a supermarket gift voucher to purchase some of the suggested food items

Breakfast is also provided on the day of all face to faceappointments

14

patients in the MedDiet

had significant improvements in insulin sensitivity as determinedby a 3-hour hyperinsulinaemic-euglycaemic clamp

significant reduction (39 ) in hepatic steatosis

low fat Diet

no significant improvement in insulin sensitivity and only a 7 reduction of hepatic steatosis with the low fat high carbohydrate diet

The changes observed in the intervention group were without a significantreduction in weight

15

The MedDiet has positive effects on insulin sensitivity which has been attributed to

the high content of bio-active phytochemicals with a range of antioxidant and anti-inflammatory activity

The MedDiet is characterised by a specific fatty acid profile low in saturated fat (7ndash8 of total energy) and high in monounsaturated fat(20 of total energy)

16

Although environmental influences such as diet have awell-established association with disease it is important to acknowledge that the interplay of genetics and environment are a widely accepted influence in disease outcomes

Currently there are no safe or effective proven therapiesfor the treatment of patients with NAFLD or NASH While diet and lifestyle changes focussing on achievingweight loss are the accepted recommendations for this patientGroupEnjoy your food eat whatrsquos good for you in moderation and remember the words of

ldquoLet food be the medicine and medicine be the foodrdquo

17

controlled trial of randomisedA ) 2016J( AmandaStuart KElena Sa Mediterranean Dietary Intervention for Adults with Non Alcoholic Fatty Liver Disease (MEDINA) study

3-0426-016-12876s118610)pp 14(16protocol

httpwwwdietplan-101commediterranean-diet-meal-planning-things-to-keep-in-mind

8

Are Non-English speaking

Consume on average gt140 gweek of alcohol (men and women)

Are taking the following medicationsimmunosuppressants amiodarone andor perhexiline

Have a HbA1c score exceeding 8

Have clinically relevant pulmonary gastro-intestinal renal metabolic hematological neurological

Are women who are pregnant

Have psychosocial or gastrointestinal (eg malabsorptiveconditions eg coeliac)

Age gt18 years

(BMI) between 20 and 399 kgm2

diagnosis of NAFLD determined

by routine ultrasound or biopsy

insulin resistance based on a HOMA IR score of gt2 and at least one elevated

serum ALT level (gt20 UL female gt30 UL male) during the past 6 months

9

10

The intervention is based on

11

LOW FAT DIETMEDITERRANEAN FOOD PYRAMID VS

12

All participants will be provided with written resources specifically designed to explain the and how it can be successfully followed and adhered to These resourcestMedDie

include

A food pyramid

healthy eating guidelines and tips

meal plans

recipes in the form of The Mediterranean Diet

a shopping list label reading

Participants will also be supplied with extra virgin olive oil

nuts

canned legumes

Fish

Breakfast is also provided on the day of all face to face appointments

13

Low fat diet

The LFD group will follow the same structure as theMedDiet arm with three face to face consultations atbaseline 6 weeks (mid intervention) and 12 weeks (endof intervention)

There will also be the same number of phone call follow ups at weeks 2 4 and 9

Participants will also be given a supermarket gift voucher to purchase some of the suggested food items

Breakfast is also provided on the day of all face to faceappointments

14

patients in the MedDiet

had significant improvements in insulin sensitivity as determinedby a 3-hour hyperinsulinaemic-euglycaemic clamp

significant reduction (39 ) in hepatic steatosis

low fat Diet

no significant improvement in insulin sensitivity and only a 7 reduction of hepatic steatosis with the low fat high carbohydrate diet

The changes observed in the intervention group were without a significantreduction in weight

15

The MedDiet has positive effects on insulin sensitivity which has been attributed to

the high content of bio-active phytochemicals with a range of antioxidant and anti-inflammatory activity

The MedDiet is characterised by a specific fatty acid profile low in saturated fat (7ndash8 of total energy) and high in monounsaturated fat(20 of total energy)

16

Although environmental influences such as diet have awell-established association with disease it is important to acknowledge that the interplay of genetics and environment are a widely accepted influence in disease outcomes

Currently there are no safe or effective proven therapiesfor the treatment of patients with NAFLD or NASH While diet and lifestyle changes focussing on achievingweight loss are the accepted recommendations for this patientGroupEnjoy your food eat whatrsquos good for you in moderation and remember the words of

ldquoLet food be the medicine and medicine be the foodrdquo

17

controlled trial of randomisedA ) 2016J( AmandaStuart KElena Sa Mediterranean Dietary Intervention for Adults with Non Alcoholic Fatty Liver Disease (MEDINA) study

3-0426-016-12876s118610)pp 14(16protocol

httpwwwdietplan-101commediterranean-diet-meal-planning-things-to-keep-in-mind

9

10

The intervention is based on

11

LOW FAT DIETMEDITERRANEAN FOOD PYRAMID VS

12

All participants will be provided with written resources specifically designed to explain the and how it can be successfully followed and adhered to These resourcestMedDie

include

A food pyramid

healthy eating guidelines and tips

meal plans

recipes in the form of The Mediterranean Diet

a shopping list label reading

Participants will also be supplied with extra virgin olive oil

nuts

canned legumes

Fish

Breakfast is also provided on the day of all face to face appointments

13

Low fat diet

The LFD group will follow the same structure as theMedDiet arm with three face to face consultations atbaseline 6 weeks (mid intervention) and 12 weeks (endof intervention)

There will also be the same number of phone call follow ups at weeks 2 4 and 9

Participants will also be given a supermarket gift voucher to purchase some of the suggested food items

Breakfast is also provided on the day of all face to faceappointments

14

patients in the MedDiet

had significant improvements in insulin sensitivity as determinedby a 3-hour hyperinsulinaemic-euglycaemic clamp

significant reduction (39 ) in hepatic steatosis

low fat Diet

no significant improvement in insulin sensitivity and only a 7 reduction of hepatic steatosis with the low fat high carbohydrate diet

The changes observed in the intervention group were without a significantreduction in weight

15

The MedDiet has positive effects on insulin sensitivity which has been attributed to

the high content of bio-active phytochemicals with a range of antioxidant and anti-inflammatory activity

The MedDiet is characterised by a specific fatty acid profile low in saturated fat (7ndash8 of total energy) and high in monounsaturated fat(20 of total energy)

16

Although environmental influences such as diet have awell-established association with disease it is important to acknowledge that the interplay of genetics and environment are a widely accepted influence in disease outcomes

Currently there are no safe or effective proven therapiesfor the treatment of patients with NAFLD or NASH While diet and lifestyle changes focussing on achievingweight loss are the accepted recommendations for this patientGroupEnjoy your food eat whatrsquos good for you in moderation and remember the words of

ldquoLet food be the medicine and medicine be the foodrdquo

17

controlled trial of randomisedA ) 2016J( AmandaStuart KElena Sa Mediterranean Dietary Intervention for Adults with Non Alcoholic Fatty Liver Disease (MEDINA) study

3-0426-016-12876s118610)pp 14(16protocol

httpwwwdietplan-101commediterranean-diet-meal-planning-things-to-keep-in-mind

10

The intervention is based on

11

LOW FAT DIETMEDITERRANEAN FOOD PYRAMID VS

12

All participants will be provided with written resources specifically designed to explain the and how it can be successfully followed and adhered to These resourcestMedDie

include

A food pyramid

healthy eating guidelines and tips

meal plans

recipes in the form of The Mediterranean Diet

a shopping list label reading

Participants will also be supplied with extra virgin olive oil

nuts

canned legumes

Fish

Breakfast is also provided on the day of all face to face appointments

13

Low fat diet

The LFD group will follow the same structure as theMedDiet arm with three face to face consultations atbaseline 6 weeks (mid intervention) and 12 weeks (endof intervention)

There will also be the same number of phone call follow ups at weeks 2 4 and 9

Participants will also be given a supermarket gift voucher to purchase some of the suggested food items

Breakfast is also provided on the day of all face to faceappointments

14

patients in the MedDiet

had significant improvements in insulin sensitivity as determinedby a 3-hour hyperinsulinaemic-euglycaemic clamp

significant reduction (39 ) in hepatic steatosis

low fat Diet

no significant improvement in insulin sensitivity and only a 7 reduction of hepatic steatosis with the low fat high carbohydrate diet

The changes observed in the intervention group were without a significantreduction in weight

15

The MedDiet has positive effects on insulin sensitivity which has been attributed to

the high content of bio-active phytochemicals with a range of antioxidant and anti-inflammatory activity

The MedDiet is characterised by a specific fatty acid profile low in saturated fat (7ndash8 of total energy) and high in monounsaturated fat(20 of total energy)

16

Although environmental influences such as diet have awell-established association with disease it is important to acknowledge that the interplay of genetics and environment are a widely accepted influence in disease outcomes

Currently there are no safe or effective proven therapiesfor the treatment of patients with NAFLD or NASH While diet and lifestyle changes focussing on achievingweight loss are the accepted recommendations for this patientGroupEnjoy your food eat whatrsquos good for you in moderation and remember the words of

ldquoLet food be the medicine and medicine be the foodrdquo

17

controlled trial of randomisedA ) 2016J( AmandaStuart KElena Sa Mediterranean Dietary Intervention for Adults with Non Alcoholic Fatty Liver Disease (MEDINA) study

3-0426-016-12876s118610)pp 14(16protocol

httpwwwdietplan-101commediterranean-diet-meal-planning-things-to-keep-in-mind

11

LOW FAT DIETMEDITERRANEAN FOOD PYRAMID VS

12

All participants will be provided with written resources specifically designed to explain the and how it can be successfully followed and adhered to These resourcestMedDie

include

A food pyramid

healthy eating guidelines and tips

meal plans

recipes in the form of The Mediterranean Diet

a shopping list label reading

Participants will also be supplied with extra virgin olive oil

nuts

canned legumes

Fish

Breakfast is also provided on the day of all face to face appointments

13

Low fat diet

The LFD group will follow the same structure as theMedDiet arm with three face to face consultations atbaseline 6 weeks (mid intervention) and 12 weeks (endof intervention)

There will also be the same number of phone call follow ups at weeks 2 4 and 9

Participants will also be given a supermarket gift voucher to purchase some of the suggested food items

Breakfast is also provided on the day of all face to faceappointments

14

patients in the MedDiet

had significant improvements in insulin sensitivity as determinedby a 3-hour hyperinsulinaemic-euglycaemic clamp

significant reduction (39 ) in hepatic steatosis

low fat Diet

no significant improvement in insulin sensitivity and only a 7 reduction of hepatic steatosis with the low fat high carbohydrate diet

The changes observed in the intervention group were without a significantreduction in weight

15

The MedDiet has positive effects on insulin sensitivity which has been attributed to

the high content of bio-active phytochemicals with a range of antioxidant and anti-inflammatory activity

The MedDiet is characterised by a specific fatty acid profile low in saturated fat (7ndash8 of total energy) and high in monounsaturated fat(20 of total energy)

16

Although environmental influences such as diet have awell-established association with disease it is important to acknowledge that the interplay of genetics and environment are a widely accepted influence in disease outcomes

Currently there are no safe or effective proven therapiesfor the treatment of patients with NAFLD or NASH While diet and lifestyle changes focussing on achievingweight loss are the accepted recommendations for this patientGroupEnjoy your food eat whatrsquos good for you in moderation and remember the words of

ldquoLet food be the medicine and medicine be the foodrdquo

17

controlled trial of randomisedA ) 2016J( AmandaStuart KElena Sa Mediterranean Dietary Intervention for Adults with Non Alcoholic Fatty Liver Disease (MEDINA) study

3-0426-016-12876s118610)pp 14(16protocol

httpwwwdietplan-101commediterranean-diet-meal-planning-things-to-keep-in-mind

12

All participants will be provided with written resources specifically designed to explain the and how it can be successfully followed and adhered to These resourcestMedDie

include

A food pyramid

healthy eating guidelines and tips

meal plans

recipes in the form of The Mediterranean Diet

a shopping list label reading

Participants will also be supplied with extra virgin olive oil

nuts

canned legumes

Fish

Breakfast is also provided on the day of all face to face appointments

13

Low fat diet

The LFD group will follow the same structure as theMedDiet arm with three face to face consultations atbaseline 6 weeks (mid intervention) and 12 weeks (endof intervention)

There will also be the same number of phone call follow ups at weeks 2 4 and 9

Participants will also be given a supermarket gift voucher to purchase some of the suggested food items

Breakfast is also provided on the day of all face to faceappointments

14

patients in the MedDiet

had significant improvements in insulin sensitivity as determinedby a 3-hour hyperinsulinaemic-euglycaemic clamp

significant reduction (39 ) in hepatic steatosis

low fat Diet

no significant improvement in insulin sensitivity and only a 7 reduction of hepatic steatosis with the low fat high carbohydrate diet

The changes observed in the intervention group were without a significantreduction in weight

15

The MedDiet has positive effects on insulin sensitivity which has been attributed to

the high content of bio-active phytochemicals with a range of antioxidant and anti-inflammatory activity

The MedDiet is characterised by a specific fatty acid profile low in saturated fat (7ndash8 of total energy) and high in monounsaturated fat(20 of total energy)

16

Although environmental influences such as diet have awell-established association with disease it is important to acknowledge that the interplay of genetics and environment are a widely accepted influence in disease outcomes

Currently there are no safe or effective proven therapiesfor the treatment of patients with NAFLD or NASH While diet and lifestyle changes focussing on achievingweight loss are the accepted recommendations for this patientGroupEnjoy your food eat whatrsquos good for you in moderation and remember the words of

ldquoLet food be the medicine and medicine be the foodrdquo

17

controlled trial of randomisedA ) 2016J( AmandaStuart KElena Sa Mediterranean Dietary Intervention for Adults with Non Alcoholic Fatty Liver Disease (MEDINA) study

3-0426-016-12876s118610)pp 14(16protocol

httpwwwdietplan-101commediterranean-diet-meal-planning-things-to-keep-in-mind

13

Low fat diet

The LFD group will follow the same structure as theMedDiet arm with three face to face consultations atbaseline 6 weeks (mid intervention) and 12 weeks (endof intervention)

There will also be the same number of phone call follow ups at weeks 2 4 and 9

Participants will also be given a supermarket gift voucher to purchase some of the suggested food items

Breakfast is also provided on the day of all face to faceappointments

14

patients in the MedDiet

had significant improvements in insulin sensitivity as determinedby a 3-hour hyperinsulinaemic-euglycaemic clamp

significant reduction (39 ) in hepatic steatosis

low fat Diet

no significant improvement in insulin sensitivity and only a 7 reduction of hepatic steatosis with the low fat high carbohydrate diet

The changes observed in the intervention group were without a significantreduction in weight

15

The MedDiet has positive effects on insulin sensitivity which has been attributed to

the high content of bio-active phytochemicals with a range of antioxidant and anti-inflammatory activity

The MedDiet is characterised by a specific fatty acid profile low in saturated fat (7ndash8 of total energy) and high in monounsaturated fat(20 of total energy)

16

Although environmental influences such as diet have awell-established association with disease it is important to acknowledge that the interplay of genetics and environment are a widely accepted influence in disease outcomes

Currently there are no safe or effective proven therapiesfor the treatment of patients with NAFLD or NASH While diet and lifestyle changes focussing on achievingweight loss are the accepted recommendations for this patientGroupEnjoy your food eat whatrsquos good for you in moderation and remember the words of

ldquoLet food be the medicine and medicine be the foodrdquo

17

controlled trial of randomisedA ) 2016J( AmandaStuart KElena Sa Mediterranean Dietary Intervention for Adults with Non Alcoholic Fatty Liver Disease (MEDINA) study

3-0426-016-12876s118610)pp 14(16protocol

httpwwwdietplan-101commediterranean-diet-meal-planning-things-to-keep-in-mind

14

patients in the MedDiet

had significant improvements in insulin sensitivity as determinedby a 3-hour hyperinsulinaemic-euglycaemic clamp

significant reduction (39 ) in hepatic steatosis

low fat Diet

no significant improvement in insulin sensitivity and only a 7 reduction of hepatic steatosis with the low fat high carbohydrate diet

The changes observed in the intervention group were without a significantreduction in weight

15

The MedDiet has positive effects on insulin sensitivity which has been attributed to

the high content of bio-active phytochemicals with a range of antioxidant and anti-inflammatory activity

The MedDiet is characterised by a specific fatty acid profile low in saturated fat (7ndash8 of total energy) and high in monounsaturated fat(20 of total energy)

16

Although environmental influences such as diet have awell-established association with disease it is important to acknowledge that the interplay of genetics and environment are a widely accepted influence in disease outcomes

Currently there are no safe or effective proven therapiesfor the treatment of patients with NAFLD or NASH While diet and lifestyle changes focussing on achievingweight loss are the accepted recommendations for this patientGroupEnjoy your food eat whatrsquos good for you in moderation and remember the words of

ldquoLet food be the medicine and medicine be the foodrdquo

17

controlled trial of randomisedA ) 2016J( AmandaStuart KElena Sa Mediterranean Dietary Intervention for Adults with Non Alcoholic Fatty Liver Disease (MEDINA) study

3-0426-016-12876s118610)pp 14(16protocol

httpwwwdietplan-101commediterranean-diet-meal-planning-things-to-keep-in-mind

15

The MedDiet has positive effects on insulin sensitivity which has been attributed to

the high content of bio-active phytochemicals with a range of antioxidant and anti-inflammatory activity

The MedDiet is characterised by a specific fatty acid profile low in saturated fat (7ndash8 of total energy) and high in monounsaturated fat(20 of total energy)

16

Although environmental influences such as diet have awell-established association with disease it is important to acknowledge that the interplay of genetics and environment are a widely accepted influence in disease outcomes

Currently there are no safe or effective proven therapiesfor the treatment of patients with NAFLD or NASH While diet and lifestyle changes focussing on achievingweight loss are the accepted recommendations for this patientGroupEnjoy your food eat whatrsquos good for you in moderation and remember the words of

ldquoLet food be the medicine and medicine be the foodrdquo

17

controlled trial of randomisedA ) 2016J( AmandaStuart KElena Sa Mediterranean Dietary Intervention for Adults with Non Alcoholic Fatty Liver Disease (MEDINA) study

3-0426-016-12876s118610)pp 14(16protocol

httpwwwdietplan-101commediterranean-diet-meal-planning-things-to-keep-in-mind

16

Although environmental influences such as diet have awell-established association with disease it is important to acknowledge that the interplay of genetics and environment are a widely accepted influence in disease outcomes

Currently there are no safe or effective proven therapiesfor the treatment of patients with NAFLD or NASH While diet and lifestyle changes focussing on achievingweight loss are the accepted recommendations for this patientGroupEnjoy your food eat whatrsquos good for you in moderation and remember the words of

ldquoLet food be the medicine and medicine be the foodrdquo

17

controlled trial of randomisedA ) 2016J( AmandaStuart KElena Sa Mediterranean Dietary Intervention for Adults with Non Alcoholic Fatty Liver Disease (MEDINA) study

3-0426-016-12876s118610)pp 14(16protocol

httpwwwdietplan-101commediterranean-diet-meal-planning-things-to-keep-in-mind

17

controlled trial of randomisedA ) 2016J( AmandaStuart KElena Sa Mediterranean Dietary Intervention for Adults with Non Alcoholic Fatty Liver Disease (MEDINA) study

3-0426-016-12876s118610)pp 14(16protocol

httpwwwdietplan-101commediterranean-diet-meal-planning-things-to-keep-in-mind

18

Thank you for your attention

Any questions