Does the presence or absence of the gene for PNPLA3 affect response to a change in diet in people with non-alcoholic fatty liver disease (NAFLD)?

Personalised nutrition in non-alcoholic fatty liver disease (NAFLD): Feasibility of a nutrigenomic therapeutic approach

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN93410321

Enrollment

Registered

2020-02-10

Start date

2020-02-11

Completion date

Unknown

Last updated

2023-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-alcoholic fatty liver disease (NAFLD) Digestive System

Interventions

Experimental: Mediterranean Diet. Participants attend one session focused on the Mediterranean diet and undertake this diet for 4 weeks, until wash-out (4 weeks). Diet education and counseling will be

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged 18-80 years 2. NAFLD confirmed on liver biopsy or by clinical diagnosis with imaging evidence of steatosis 3. Weekly alcohol consumption <14 units (women) or <21 units (men) in last 24 months 4. Weight stable (+/-5%) for 3 months 5. Capacity to provide informed consent. 6. Ability to write and converse in English without assistance of an interpreter

Exclusion criteria

Exclusion criteria: 1. Liver neoplasm/cancer within 5 years (except squamous cell carcinoma) 2. Evidence of co-existent liver disease/presence of secondary causes of NAFLD (except Gilbert's syndrome). 3. Decompensated NASH-cirrhosis (Child Pugh >5-6) 4. Uncontrolled psychiatric disorder (e.g. acute psychosis) 5. Uncontrolled medical condition (e.g. HbA1c >80mmol/l or acute coronary event or stroke within 12 months) 6. Active eating disorder 7. Active substance misuse 8. Prescribed other dietary regimens+/-food intolerances or food allergies 9. Mediterranean diet point score (MEDAS) >8 (high MD consumption) 10. Previous weight loss surgery 11. Taking anti-obesity medications+/-engaged in structured, multi-component weight management interventions (specialist, community or commercial providers) 12. Insulin use 13. Pregnancy/ lactation

Design outcomes

Primary

Measure	Time frame
1. Quality of life assessed using the EQ5D, CLDQ-NASH and NASH-CHECK questionnaires at 4 and 12 weeks 2. Recruitment rate (number of participants recruited per month) assessed using the trial log between baseline and 12 months 3. Consent rate (number of eligible participants who consent divided by the total number who are eligible) assessed using the trial log between baseline and 12 months 4. Retention rate (number of participants who complete follow-up data collection divided by the total number randomised) assessed using the trial log between baseline and 12 months 5. Participant adherence to trial procedures assessed by tracking the number of completed visits and completeness of data collection assessed using the trial log between baseline and 12 months 6. Data collection burden will be measured by the time taken to administer protocol processes using the trial log between baseline and 12 months 7. Participant processing (the number of days from initial contact to enrolment) assessed using the trial log between baseline and 12 months 8. Missing, incomplete or unreliable data recorded using a trial protocol checklist between baseline and 12 months. These data will be used to calculate data integrity and fidelity.	—

Measure

Time frame

1. Quality of life assessed using the EQ5D, CLDQ-NASH and NASH-CHECK questionnaires at 4 and 12 weeks 2. Recruitment rate (number of participants recruited per month) assessed using the trial log between baseline and 12 months 3. Consent rate (number of eligible participants who consent divided by the total number who are eligible) assessed using the trial log between baseline and 12 months 4. Retention rate (number of participants who complete follow-up data collection divided by the total number randomised) assessed using the trial log between baseline and 12 months 5. Participant adherence to trial procedures assessed by tracking the number of completed visits and completeness of data collection assessed using the trial log between baseline and 12 months 6. Data collection burden will be measured by the time taken to administer protocol processes using the trial log between baseline and 12 months 7. Participant processing (the number of days from initial contact to enrolment) assessed using the trial log between baseline and 12 months 8. Missing, incomplete or unreliable data recorded using a trial protocol checklist between baseline and 12 months. These data will be used to calculate data integrity and fidelity.

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Secondary

Measure	Time frame
1. Body weight assessed using bioimpedance at baseline, 4, 8 and 12 weeks 2. Height assessed using a stadiometer at baseline, 4, 8 and 12 weeks 3. Waist and hip circumference assessed using a tape measure at baseline, 4, 8 and 12 weeks. These measurements will be used to calculate waist-to-hip ratio. 4. Body composition measured using a bioelectrical impedance body composition analyser 5. Hepatic steatosis assessed by measuring controlled attenuation parameter (CAP) by transient elastography (Fibroscan) at baseline 6. Hepatic fibrosis assessed by measuring liver stiffness by transient elastography (Fibroscan) at baseline 7. Levels of dietary biomarkers in urine assessed by mass spectrometry at baseline, 4, 8 and 12 weeks 8. Levels of lipid biomarkers assessed by mass spectrometry in fasted blood samples taken at baseline, 4, 8 and 12 weeks 9. Liver function assessed using liver function tests on fasted blood samples taken at baseline, 4, 8 and 12 weeks 10. Levels of ferritin measured using standard procedures by the hospital’s laboratory service in fasted blood samples taken at baseline, 4, 8 and 12 weeks 11. Full blood count measured using standard procedures by the hospital’s laboratory service in fasted blood samples taken at baseline, 4, 8 and 12 weeks 12. Levels of liver function biomarkers assessed by ELISA in fasted blood samples taken at baseline, 4, 8 and 12 weeks 13. Inflammation assessed using levels of C-reactive protein (CRP) measured using standard procedures by the hospital’s laboratory service in fasted blood samples taken at baseline, 4, 8 and 12 weeks 14. Lipid profile measured using standard procedures by the hospital’s laboratory service in fasted blood samples taken at baseline, 4, 8 and 12 weeks 15. Blood glucose level measured using standard procedures by the hospital’s laboratory service in fasted blood samples taken at baseline, 4, 8 and 12 weeks 16. Glycated haemoglobin (HbA1c) level measured using standard procedures by the hospital’s l	—

Measure

Time frame

1. Body weight assessed using bioimpedance at baseline, 4, 8 and 12 weeks 2. Height assessed using a stadiometer at baseline, 4, 8 and 12 weeks 3. Waist and hip circumference assessed using a tape measure at baseline, 4, 8 and 12 weeks. These measurements will be used to calculate waist-to-hip ratio. 4. Body composition measured using a bioelectrical impedance body composition analyser 5. Hepatic steatosis assessed by measuring controlled attenuation parameter (CAP) by transient elastography (Fibroscan) at baseline 6. Hepatic fibrosis assessed by measuring liver stiffness by transient elastography (Fibroscan) at baseline 7. Levels of dietary biomarkers in urine assessed by mass spectrometry at baseline, 4, 8 and 12 weeks 8. Levels of lipid biomarkers assessed by mass spectrometry in fasted blood samples taken at baseline, 4, 8 and 12 weeks 9. Liver function assessed using liver function tests on fasted blood samples taken at baseline, 4, 8 and 12 weeks 10. Levels of ferritin measured using standard procedures by the hospital’s laboratory service in fasted blood samples taken at baseline, 4, 8 and 12 weeks 11. Full blood count measured using standard procedures by the hospital’s laboratory service in fasted blood samples taken at baseline, 4, 8 and 12 weeks 12. Levels of liver function biomarkers assessed by ELISA in fasted blood samples taken at baseline, 4, 8 and 12 weeks 13. Inflammation assessed using levels of C-reactive protein (CRP) measured using standard procedures by the hospital’s laboratory service in fasted blood samples taken at baseline, 4, 8 and 12 weeks 14. Lipid profile measured using standard procedures by the hospital’s laboratory service in fasted blood samples taken at baseline, 4, 8 and 12 weeks 15. Blood glucose level measured using standard procedures by the hospital’s laboratory service in fasted blood samples taken at baseline, 4, 8 and 12 weeks 16. Glycated haemoglobin (HbA1c) level measured using standard procedures by the hospital’s l

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Countries

England, United Kingdom

Contacts

Public ContactLaura Haigh

laura.haigh@newcastle.ac.uk+44 (0)191 223 1568

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 15, 2026