Effects of Fructose Restriction on Liver Steatosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Change in intrahepatic triglyceride content
研究概览
简要总结
Nonalcoholic fatty liver disease (NAFLD) is an emerging health problem as it can lead to end stage liver failure and cardiovascular complications. Diet play an important role in the development of NAFLD. Many studies have addressed the effects of added fructose on NAFLD. To date, little attention has been paid to the effects of a diet devoid of fructose. Therefore, the investigators aim to study the effects of fructose restriction on hepatic fat accumulation and vascular function using a double-blind randomized placebo-controlled design.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 18 years
- •Body mass index ≥ 28 kg/m2
- •Fatty liver index ≥ 60
- •Fructose intake ≥45 grams/day
排除标准
- •Medical history of liver disease
- •(History of) excessive alcohol consumption (defined as > 2 units/day for women, and > 3 units/day for men)
- •Major change in weight and/or physical activity prior to the study
- •Use of glucose lowering drugs
- •Recent illness
- •Pregnancy and/or lactation
- •Contraindications for magnetic resonance imaging
- •Inability to give informed consent
- •Protocol change (implemented on July 18, 2018): in order to increase the inclusion of study participants, subjects with an average daily fructose intake < 45 gram/day will also be eligible for participation. In subjects who have an average daily fructose intake < 45 gram/day, supplementation of either fructose or glucose (see 'Arms and Interventions') will be increased to 45 gram/day.
研究组 & 干预措施
Glucose
Participants will follow a six-week low fructose diet. The amount of restricted fructose will be supplemented as glucose powder.
干预措施: Glucose (Dietary Supplement)
Fructose
Participants will follow a six-week low fructose diet. The amount of restricted fructose will be supplemented as fructose powder.
干预措施: Fructose (Dietary Supplement)
结局指标
主要结局
Change in intrahepatic triglyceride content
时间窗: 6 weeks
Assessed by magnetic resonance spectroscopy
次要结局
- Change in arterial stiffness (PWV)(6 weeks)
- Change in endothelial function (RHI)(6 weeks)
- Change in endothelial function (panel of endothelial dysfunction biomarkers)(6 weeks)
- Change in endothelial function (flowmotion and skin heating response)(6 weeks)
- Change in glucose metabolism(6 weeks)