Status:
UNKNOWN
Low GI Diet Effects on Non-Alcoholic Fatty Liver Disease
Lead Sponsor:
University of Nottingham
Conditions:
Fatty Liver
Nutritional and Metabolic Disease
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
A 2 x 2 cross-over dietary intervention trial designed to investigate the effects of low glycemic index (LGI) versus high glycemic index (HGI) diet on hepatic fat accumulation and gut microbiota compo...
Eligibility Criteria
Inclusion
- • Adult males and females aged from 18 to 65 years (balanced number).
- Detected NAFLD by CAP-FibroScan™ \>288dB/m or by MRI-PDFF) \> 5% fat of liver weight.
- Body mass index ≥ 25 kg/m2
- Have current moderate to high GI diet intake of ≥ 60 (Assessed from a completed 7-day food diary).
- Abdominal obesity (Waist circumference \> 102 cm for males and \> 88 cm for females)
- Able to give informed consent.
- Able to undergo MRI/S and CAP-FibroScan™.
Exclusion
- • Current smokers and excessive alcohol drinkers (\> 14 units/week).
- Perimenopausal (irregular periods) women.
- Participants with other liver abnormalities.
- Participants with history of gastrointestinal surgeries, depression, eating disorders or difficulties.
- Participants using pharmacologic agents for obesity or NAFLD.
- Participants with type 1 diabetes.
- Participants with type 2 diabetes on second line medications (eg GLP-1 analogues, sulfonylureas).
- Participation in any other trial in the last 3 months.
- Participants on any special diets (e.g. vegetarians).
- Intolerance to foods included in the diet plan.
Key Trial Info
Start Date :
December 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2023
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT04415632
Start Date
December 10 2020
End Date
October 1 2023
Last Update
September 29 2021
Active Locations (1)
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1
NIHR Nottingham Clinical Research Facility Nottingham Digestive Diseases Centre
Nottingham, Nottinghamshire, United Kingdom, NG7 2UH