NCT04415632Unknown不适用
Effects of an Iso-energetic Low Glycemic Index (GI) Diet on Liver Fat Accumulation and Gut Microbiota Composition in Patients With Non- Alcoholic Fatty Liver Disease (NAFLD)
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- liver fat content
研究概览
简要总结
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 composition in participants with NAFLD.
Participants will be allocated randomly to a 2-week either high GI (HGI) or low GI (LGI) diet followed by a 4-week wash-out period and then the LGI or HGI diet, opposite to the first 2-weeks (N= 16).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• 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™.
排除标准
- •• 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.
结局指标
主要结局
liver fat content
时间窗: 2 weeks
To assess the difference in liver fat content between LGI and HGI diet groups in participants with NAFLD using MRI/S
次要结局
- Blood glucose level(2 weeks)
- Blood insulin levels(2 weeks)
- Gut microbial composition(2 weeks)
- blood liver function tests(At baseline)
- Plasma Short Chain Fatty Acids (SCFAs)(2 weeks)
- Anthropometric measurements(2 weeks)
- Body composition Fat Mass(2 weeks)
- Body composition Water Content(2 weeks)
- blood lipids levels(2 weeks)
- blood gut hormones levels(2 weeks)
- blood liver function test(2 weeks)
- Body composition Muscle Mass(2 weeks)
- Visual analogue scales (VAS)(through study completion, an average of two weeks)
研究者
研究点 (2)
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