Long-term Investigation of Resveratrol in Obesity

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Long-term Investigation of Resveratrol on Management of Metabolic Syndrome, Osteoporosis and Inflammation, and Identification of Plant Derived Anti-inflammatory Compounds

Conditions
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Obesity, Inflammation, Insulin Sensitivity, Osteoporosis

Intervention / Treatment
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* Dietary Supplement: Resveratrol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male 30-60 years old Metabolic Syndrome Written informed consent Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Dietary Supplement: Resveratrol<br>* 500mg resveratrol 2 times daily for 4 months (High-dose Resveratrol), 75mg resveratrol 2 times daily for 4 months (Low-dose Resveratrol) or 1 placebo 2 times daily for 4 months<br>|
| Experimental: High-dose Resveratrol<br> | Dietary Supplement: Resveratrol<br>* 500mg resveratrol 2 times daily for 4 months (High-dose Resveratrol), 75mg resveratrol 2 times daily for 4 months (Low-dose Resveratrol) or 1 placebo 2 times daily for 4 months<br>|
| Experimental: Low-dose Resveratrol<br> | Dietary Supplement: Resveratrol<br>* 500mg resveratrol 2 times daily for 4 months (High-dose Resveratrol), 75mg resveratrol 2 times daily for 4 months (Low-dose Resveratrol) or 1 placebo 2 times daily for 4 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from Baseline in markers of inflammation (hs-CRP) in blood after 4 months of treatment with either resveratrol or placebo |  | 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Resveratrol, Obesity, Inflammation, Metabolic Syndrome, Insulin sensitivity, Osteoporosis, Bone turnover, Ectopic fat accumulation