Long-term Investigation of Resveratrol in Obesity

Not Applicable

Completed

• Conditions: Osteoporosis; Obesity; Insulin Sensitivity; Inflammation
• Interventions: Dietary Supplement: Resveratrol

• Registration Number: NCT01412645
• Lead Sponsor: University of Aarhus

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2011-07-13
• Study Start: 2011-08
• Study First Submitted QC: 2011-08-08
• Study First Posted: 2011-08-09
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-12
• Last Update Posted: 2013-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 76

Inclusion Criteria

• Male
• 30-60 years old
• Metabolic Syndrome
• Written informed consent

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Resveratrol	-
High-dose Resveratrol	Resveratrol	-
Low-dose Resveratrol	Resveratrol	-

Primary Outcome Measures

Name	Time	Method
Changes from Baseline in markers of inflammation (hs-CRP) in blood after 4 months of treatment with either resveratrol or placebo	4 months

Trial Locations

Locations (1)

Clinical Institute, Aarhus University; 🇩🇰 Aarhus, Denmark