NCT01446276已完成不适用
Long-term Investigation of Resveratrol on Lipid Turnover in Obese Men With Nonalcoholic Fatty Liver Disease. Effects on Liver Fat Content and Basal and Insulin Stimulated FFA and VLDL-triglyceride Metabolism
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Hepatic VLDL-TG secretion and peripheral VLDL-TG clearance
研究概览
简要总结
The purpose of this study is to investigate potential metabolic effects of resveratrol in obese healthy men with non-alcoholic fatty liver disease.
The investigators hypothesize that resveratrol will:
- decrease hepatic very-low-density-lipoprotein-triglyceride (VLDL-TG) secretion
- decrease liver fat content
- increase insulin sensitivity
The investigators will look at changes in:
- lipid turnover (VLDL-TG kinetics, palmitate kinetics, indirect calorimetry)
- liver fat content (MR liver spectroscopy)
- insulin sensitivity (glucose kinetics during hyperinsulinaemic euglycaemic clamp)
- body composition (DXA and MRI)
- lipase activity and fat cell size (fat biopsy from abdominal and femoral adipose tissue)
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •25-65 years
- •Obesity (BMI > 28 kg/m2, waist/hip ratio > 0,95)
- •Have nonalcoholic fatty liver disease (NAFLD)(intervention group) or do not have NAFLD (control group)
- •May have hypertension and/or hypercholesterolemia
- •Written informed consent
排除标准
- •Any other disease than NAFLD (e.g. diabetes, thyroid or parathyroid disease, heart, liver or kidney disease)
- •Present and previous malignancy
- •Alcohol dependency (more than 21 units of alcohol per week)
- •History of smoking
- •Participation in studies with radioactive isotopes within the last six months
- •Hemoglobin under normal range regarding to sex (under 8.3 mmol/l for men)
结局指标
主要结局
Hepatic VLDL-TG secretion and peripheral VLDL-TG clearance
时间窗: six month
- Changes from baseline after treatment with either resveratrol or placebo
次要结局
- VLDL-TG oxidation(six month)
- Body composition (fat mass, fat-free mass, percent fat, visceral fat mass)(six month)
- Basal and insulin stimulated free fatty acid (FFA) and glucose turnover(six month)
- lipoprotein lipase activity and fat cell size in abdominal and femoral adipose tissue biopsy(six months)
- Baseline data(Baseline)
研究者
研究点 (2)
Loading locations...
相似试验
Unknown
不适用
Short-term Investigation of Resveratrol on Fat Metabolism in Morbidly Obese Women Undergoing Gastric Bypass SurgeryObesityNCT01826279University of Aarhus16
已完成
不适用
Long-term Investigation of Resveratrol in ObesityInflammationInsulin SensitivityObesityOsteoporosisNCT01412645University of Aarhus76
已完成
不适用
Resveratrol and Huntington DiseaseHuntington DiseaseNCT02336633Assistance Publique - Hôpitaux de Paris102
已完成
2 期
The Effects of Resveratrol Supplement on Biochemical Factors and Hepatic Fibrosis in Patients With Nonalcoholic SteatohepatitisNon Alcoholic Fatty LiverNCT02030977Dr Azita Hekmatdoost50
招募中
不适用
Autonomic and Cardiovascular Recovery After the Acute Use of Resveratrol in Overweight and Obesity IndividualsPolyphenolsCardiovascular DiseasesAutonomic Nervous SystemNCT06020313Taisy Cinthia Ferro Cavalcante30