Long-term Investigation of Resveratrol in Obesity
LIRMOI
1 other identifier
interventional
76
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable obesity
Started Aug 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 13, 2011
CompletedStudy Start
First participant enrolled
August 1, 2011
CompletedFirst Posted
Study publicly available on registry
August 9, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedDecember 13, 2013
December 1, 2013
2 years
July 13, 2011
December 12, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes from Baseline in markers of inflammation (hs-CRP) in blood after 4 months of treatment with either resveratrol or placebo
4 months
Study Arms (3)
Placebo
PLACEBO COMPARATORHigh-dose Resveratrol
EXPERIMENTALLow-dose Resveratrol
EXPERIMENTALInterventions
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
Eligibility Criteria
You may qualify if:
- Male
- years old
- Metabolic Syndrome
- Written informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Aarhuslead
- The Ministry of Science, Technology and Innovation, Denmarkcollaborator
- Central Denmark Regioncollaborator
Study Sites (1)
Clinical Institute, Aarhus University
Aarhus, Aarhus, 8000, Denmark
Related Publications (2)
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.
PMID: 28182820DERIVEDOrnstrup 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.
PMID: 25322274DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Steen B Pedersen, MD, PhD
University of Aarhus
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 13, 2011
First Posted
August 9, 2011
Study Start
August 1, 2011
Primary Completion
August 1, 2013
Study Completion
August 1, 2013
Last Updated
December 13, 2013
Record last verified: 2013-12