Effects of Long-term Resveratrol Supplementation on Metabolic Health
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Change in Glucose Tolerance
研究概览
简要总结
The main objective of the study is to investigate if 6 months resveratrol supplementation can improve glucose tolerance in overweight/obese individuals. As secondary objectives we want to investigate whether resting energy metabolism, intra-hepatic lipid content, physical performance, body composition and quality of life change by 6 months resveratrol supplementation in these individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men aged 40-70 years and postmenopausal women aged 50-70 years
- •BMI: 27-35 kg/m2
- •Stable dietary habits: no weight gain or loss > 5kg in the last three months
- •Willingness to limit consumption of resveratrol-containing food products and willingness to refrain from using resveratrol containing supplements
- •Subjects will only be included when the dependent medical doctor of this study approves participation after evaluating data obtained during screening
排除标准
- •Uncontrolled hypertension
- •HbA1c > 6.5%
- •Previously diagnosed with type 2 diabetes
- •Medication use known to interfere with glucose homeostasis/metabolism
- •Current alcohol consumption > 20 grams alcohol/day
- •Subjects who do not want to be informed about unexpected medical findings during the screening /study, or do not wish that their physician is informed, cannot participate in the study.
- •Participation in another biomedical study within 1 month before the start of the intervention
- •Any condition, disease or abnormal laboratory test result that, in the opinion of the Investigator, would interfere with the study outcome, affect trial participation or put the subject at undue risk
研究组 & 干预措施
Placebo
placebo will be given for 6 months, twice daily. One pill will be provided with lunch and the other pill will be provided with dinner.
干预措施: placebo (Dietary Supplement)
Resveratrol
resveratrol will be given for 6 months, twice daily. One pill, which contains 75 mg of resveratrol, will be provided with lunch, and the other pill of 75 mg will be provided with dinner. So in total 150 mg/day of resveratrol will be given.
干预措施: resveratrol (Dietary Supplement)
结局指标
主要结局
Change in Glucose Tolerance
时间窗: 2x baseline and 2x after 6 months of supplemenation
Matsuda Index calculated from double 2-hour Oral Glucose Tolerance Test (OGTT)
次要结局
- Change in Resting energy expenditure(baseline and after 6 months of supplemenation)
- Change in Body composition(baseline and after 6 months of supplemenation)
- Change in Quality of life(baseline and after 6 months of supplemenation)
- Change in Blood plasma markers(Once a month for a period of 6 months)
- Change in Blood pressure(Once a month for a period of 6 months)
- Change in Physical performance(baseline and after 6 months of supplemenation)
- Change in Quality of sleep(baseline and after 6 months of supplemenation)
- Change in Intra-hepatic lipid content(baseline and after 6 months of supplemenation)