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Long-term Investigation of Resveratrol in Obesity

NCT ID: NCT01412645

Last Updated: 2013-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2013-08-31

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.

Conditions

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Obesity Inflammation Insulin Sensitivity Osteoporosis

Keywords

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Obesity Inflammation Metabolic Syndrome Insulin sensitivity Osteoporosis Bone turnover Ectopic fat accumulation Resveratrol

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Resveratrol

Intervention Type 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

High-dose Resveratrol

Group Type EXPERIMENTAL

Resveratrol

Intervention Type 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

Low-dose Resveratrol

Group Type EXPERIMENTAL

Resveratrol

Intervention Type 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

Interventions

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Resveratrol

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

Intervention Type DIETARY_SUPPLEMENT

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
Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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The Ministry of Science, Technology and Innovation, Denmark

OTHER_GOV

Sponsor Role collaborator

Central Denmark Region

OTHER

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Steen B Pedersen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Aarhus

Locations

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Clinical Institute, Aarhus University

Aarhus, Aarhus, Denmark

Site Status

Countries

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Denmark

References

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Kjaer TN, Ornstrup MJ, Poulsen MM, Stodkilde-Jorgensen H, Jessen N, Jorgensen JOL, Richelsen B, Pedersen SB. No Beneficial Effects of Resveratrol on the Metabolic Syndrome: A Randomized Placebo-Controlled Clinical Trial. J Clin Endocrinol Metab. 2017 May 1;102(5):1642-1651. doi: 10.1210/jc.2016-2160.

Reference Type DERIVED
PMID: 28182820 (View on PubMed)

Ornstrup MJ, Harslof T, Kjaer TN, Langdahl BL, Pedersen SB. Resveratrol increases bone mineral density and bone alkaline phosphatase in obese men: a randomized placebo-controlled trial. J Clin Endocrinol Metab. 2014 Dec;99(12):4720-9. doi: 10.1210/jc.2014-2799.

Reference Type DERIVED
PMID: 25322274 (View on PubMed)

Other Identifiers

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LIRMOI

Identifier Type: -

Identifier Source: org_study_id