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)?

Not Applicable

Completed

• Conditions: on-alcoholic fatty liver disease (NAFLD); Digestive System

• Registration Number: ISRCTN93410321
• Lead Sponsor: ewcastle upon Tyne Hospitals NHS Foundation Trust

Brief Summary

2021 Protocol article in http://dx.doi.org/10.1136/bmjopen-2020-045922 (added 15/08/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-02-10
• Study Completion: 2021-09-30
• Last Update Posted: 19 December 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 49

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified