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CompletedNCT01412645LIRMOIUpdated Dec 13, 2013

Long-term Investigation of Resveratrol in Obesity

An interventional study of Resveratrol in Obesity, Inflammation and Insulin Sensitivity, sponsored by University of Aarhus. Completed at 1 site in Denmark. Open to male participants aged 30 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-12-13.

Sponsored by University of Aarhus · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
76
Allocation
Randomized
Ages
30 Years to 60 Years
Sex
Male
01

Study 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.

Read the 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.

02

Conditions studied

  • Obesity
  • Inflammation
  • Insulin Sensitivity
  • Osteoporosis

Keywords

  • Obesity
  • Inflammation
  • Metabolic Syndrome
  • Insulin sensitivity
  • Osteoporosis
  • Bone turnover
  • Ectopic fat accumulation
  • Resveratrol
03

In context

Obesity

6,570 studies on the registry are indexed under Obesity; 1,718 are open to participants now.

This study's enrollment of 76 is close to the median of 77 across 5,084 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

University of Aarhus is the lead sponsor of 1,299 studies on the registry; 189 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 60 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
76 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    Dietary Supplement: Resveratrol

  • Experimental
    High-dose Resveratrol

    Dietary Supplement: Resveratrol

  • Experimental
    Low-dose Resveratrol

    Dietary Supplement: Resveratrol

Interventions

  • Dietary supplementResveratrol

    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

06

What researchers measure

Primary outcomes

  1. 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

07

Study locations

1 site
  • Clinical Institute, Aarhus University
    Aarhus, Aarhus 8000, Denmark
08

References and documents

Publications

  • 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. PubMed 28182820 ↗
  • 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. PubMed 25322274 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 13, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01412645
Collaborators
The Ministry of Science, Technology and Innovation, Denmark, Central Denmark Region
Responsible party
Sponsor
First posted
Aug 9, 2011
Start date
Aug 2011
Primary completion
Aug 2013
Completion
Aug 2013
Last update
Dec 13, 2013

Study contacts

Steen B Pedersen, MD, PhD
principal investigator · University of Aarhus

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.

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