Back to resultsLong-term Investigation of Resveratrol in Obesity (LIRMOI)
Primary Purpose
Obesity, Inflammation, Insulin Sensitivity
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Resveratrol
Sponsored by
About this trial
This is an interventional basic science trial for Obesity focused on measuring Obesity, Inflammation, Metabolic Syndrome, Insulin sensitivity, Osteoporosis, Bone turnover, Ectopic fat accumulation, Resveratrol
Eligibility Criteria
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
Sites / Locations
- Clinical Institute, Aarhus University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
Placebo
High-dose Resveratrol
Low-dose Resveratrol
Arm Description
Outcomes
Primary Outcome Measures
Changes from Baseline in markers of inflammation (hs-CRP) in blood after 4 months of treatment with either resveratrol or placebo
Secondary Outcome Measures
Full Information
NCT ID
NCT01412645
First Posted
July 13, 2011
Last Updated
December 12, 2013
Sponsor
University of Aarhus
Collaborators
The Ministry of Science, Technology and Innovation, Denmark, Central Denmark Region
1. Study Identification
Unique Protocol Identification Number
NCT01412645
Brief Title
Long-term Investigation of Resveratrol in Obesity
Acronym
LIRMOI
Official Title
Long-term Investigation of Resveratrol on Management of Metabolic Syndrome, Osteoporosis and Inflammation, and Identification of Plant Derived Anti-inflammatory Compounds
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
The Ministry of Science, Technology and Innovation, Denmark, Central Denmark Region
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Inflammation, Insulin Sensitivity, Osteoporosis
Keywords
Obesity, Inflammation, Metabolic Syndrome, Insulin sensitivity, Osteoporosis, Bone turnover, Ectopic fat accumulation, Resveratrol
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
76 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
High-dose Resveratrol
Arm Type
Experimental
Arm Title
Low-dose Resveratrol
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Resveratrol
Intervention Description
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
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steen B Pedersen, MD, PhD
Organizational Affiliation
University of Aarhus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Institute, Aarhus University
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
28182820
Citation
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.
Results Reference
derived
PubMed Identifier
25322274
Citation
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.
Results Reference
derived
Learn more about this trial
Long-term Investigation of Resveratrol in Obesity
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