ISRCTN93410321Completed未知
Personalised nutrition in non-alcoholic fatty liver disease (NAFLD): Feasibility of a nutrigenomic therapeutic approach
ewcastle upon Tyne Hospitals NHS Foundation Trust0 sites49 target enrollmentStarted: February 10, 2020Last updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
- Enrollment
- 49
Study Overview
Brief Summary
2021 Protocol article in http://dx.doi.org/10.1136/bmjopen-2020-045922 (added 15/08/2022)
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
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
Investigators
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