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Long-term Investigation of Resveratrol in Obesity (LIRMOI)

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ClinicalTrials.gov Identifier: NCT01412645
Recruitment Status : Completed
First Posted : August 9, 2011
Last Update Posted : December 13, 2013
Sponsor:
Collaborators:
The Ministry of Science, Technology and Innovation, Denmark
Central Denmark Region
Information provided by (Responsible Party):
University of Aarhus

Tracking Information
First Submitted Date  ICMJE July 13, 2011
First Posted Date  ICMJE August 9, 2011
Last Update Posted Date December 13, 2013
Study Start Date  ICMJE August 2011
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 12, 2012)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 8, 2011)
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 ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Long-term Investigation of Resveratrol in Obesity
Official Title  ICMJE Long-term Investigation of Resveratrol on Management of Metabolic Syndrome, Osteoporosis and Inflammation, and Identification of Plant Derived Anti-inflammatory Compounds
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE
  • Obesity
  • Inflammation
  • Insulin Sensitivity
  • Osteoporosis
Intervention  ICMJE 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

Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Intervention: Dietary Supplement: Resveratrol
  • Experimental: High-dose Resveratrol
    Intervention: Dietary Supplement: Resveratrol
  • Experimental: Low-dose Resveratrol
    Intervention: Dietary Supplement: Resveratrol
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 12, 2013)
76
Original Estimated Enrollment  ICMJE
 (submitted: August 8, 2011)
80
Actual Study Completion Date  ICMJE August 2013
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 30 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01412645
Other Study ID Numbers  ICMJE LIRMOI
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Aarhus
Study Sponsor  ICMJE University of Aarhus
Collaborators  ICMJE
  • The Ministry of Science, Technology and Innovation, Denmark
  • Central Denmark Region
Investigators  ICMJE
Principal Investigator: Steen B Pedersen, MD, PhD University of Aarhus
PRS Account University of Aarhus
Verification Date December 2013

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