Long-term Investigation of Resveratrol in Obesity

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.

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Key information

Conditions

Obesity Body Weight Bone Diseases Bone Diseases, Metabolic Glucose Metabolism Disorders Hyperinsulinism Inflammation Insulin Resistance Insulin Sensitivity Metabolic Diseases Metabolic Syndrome Musculoskeletal Diseases Nutrition Disorders Nutritional and Metabolic Diseases Osteoporosis Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

30 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Institute, Aarhus University

Aarhus, 8000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Resveratrol

Dietary Supplement

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

Primary outcomes

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

Time frame: 4 months

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

Central Denmark Region
The Ministry of Science, Technology and Innovation, Denmark

Registry information

Official study title

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

Acronym: LIRMOI

Important dates

Study start: 2011
Primary completion: 2013
Study completion: 2013
First posted: Aug 9, 2011
Registry last updated: Dec 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed