NCT01412645已完成不适用
Long-term Investigation of Resveratrol on Management of Metabolic Syndrome, Osteoporosis and Inflammation, and Identification of Plant Derived Anti-inflammatory Compounds
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- Changes from Baseline in markers of inflammation (hs-CRP) in blood after 4 months of treatment with either resveratrol or placebo
研究概览
简要总结
The aim of this study is to investigate potential metabolic effects of resveratrol in men with metabolic syndrome(otherwise healthy).
The investigators hypothesize that resveratrol has an anti-inflammatory effect, and will increase insulin sensitivity, change the fat- and sugar-metabolism, and down-regulate bone-turnover.
详细描述
The study will be done in a collaboration between two PhD students, who focus on effects in adipose- and muscle- tissue, and bone tissue respectively.
The investigators will look at changes in
- inflammation-markers
- biochemical markers of fat- and sugar-metabolism
- gene-expression in fat- and muscle-tissue
- body composition (DXA (whole body) and MR spectroscopy)
- biochemical markers of bone-metabolism
- Bone Mineral Density (DXA scans)
- bone structure (QCT)
- gene-expression and cytokines in bone marrow
Some of the volunteers will have their insulin sensitivity measured.
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
- 30 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •30-60 years old
- •Metabolic Syndrome
- •Written informed consent
排除标准
- •Diabetes, thyroid or parathyroid disease, hypogonadism
- •Treatment-requiring osteoporosis
- •Heart, liver or kidney disease
- •Present or previous malignancy
- •MR contraindication
- •Alcohol dependency
- •Weight > 130 kilograms
结局指标
主要结局
Changes from Baseline in markers of inflammation (hs-CRP) in blood after 4 months of treatment with either resveratrol or placebo
时间窗: 4 months
次要结局
未报告次要终点
研究者
研究点 (2)
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