Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Long-term Investigation of Resveratrol in Obesity (LIRMOI)

This study has been completed.
Sponsor:
Collaborators:
The Ministry of Science, Technology and Innovation, Denmark
Central Denmark Region
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01412645
First received: July 13, 2011
Last updated: December 12, 2013
Last verified: December 2013

July 13, 2011
December 12, 2013
August 2011
August 2013   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Changes from Baseline in markers of inflammation (hs-CRP in blood and TNFalfa, IL1, IL6 and IL8 in adipose tissue, muscle or bonemarrow) and insulin sensitivity (assessed by HOMA) after one year of treatment with either resveratrol or placebo. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01412645 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Long-term Investigation of Resveratrol in Obesity
Long-term Investigation of Resveratrol on Management of Metabolic Syndrome, Osteoporosis and Inflammation, and Identification of Plant Derived Anti-inflammatory Compounds

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
  • Obesity
  • Inflammation
  • Insulin Sensitivity
  • Osteoporosis
Dietary Supplement: 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

  • Placebo Comparator: Placebo
    Intervention: Dietary Supplement: Resveratrol
  • Experimental: High-dose Resveratrol
    Intervention: Dietary Supplement: Resveratrol
  • Experimental: Low-dose Resveratrol
    Intervention: Dietary Supplement: Resveratrol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
76
August 2013
August 2013   (final data collection date for primary outcome measure)

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
Male
30 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01412645
LIRMOI
No
University of Aarhus
University of Aarhus
  • The Ministry of Science, Technology and Innovation, Denmark
  • Central Denmark Region
Principal Investigator: Steen B Pedersen, MD, PhD University of Aarhus
University of Aarhus
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP