Long-term Investigation of Resveratrol in Obesity (LIRMOI)

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborators:

The Ministry of Science, Technology and Innovation, Denmark

Health Research Fund of Central Denmark Region

Information provided by (Responsible Party):

University of Aarhus

ClinicalTrials.gov Identifier:

NCT01412645

First received: July 13, 2011

Last updated: April 12, 2013

Last verified: April 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

July 13, 2011

Last Updated Date

April 12, 2013

Start Date ^ICMJE

August 2011

Estimated Primary Completion Date

August 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

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 ]

Change History

Complete list of historical versions of study NCT01412645 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

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

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 Arm (s)

Placebo Comparator: Placebo
Intervention: Dietary Supplement: Resveratrol
Experimental: High-dose Resveratrol
Intervention: Dietary Supplement: Resveratrol
Experimental: Low-dose Resveratrol
Intervention: Dietary Supplement: Resveratrol

Publications *

Not Provided

* 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

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

July 2014

Estimated 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

Gender

Male

Ages

30 Years to 60 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Denmark

Administrative Information

NCT Number ^ICMJE

NCT01412645

Other Study ID Numbers ^ICMJE

LIRMOI

Has Data Monitoring Committee

Responsible Party

University of Aarhus

Study Sponsor ^ICMJE

University of Aarhus

Collaborators ^ICMJE

The Ministry of Science, Technology and Innovation, Denmark
Health Research Fund of Central Denmark Region

Investigators ^ICMJE

Principal Investigator:

Steen B Pedersen, MD, PhD

University of Aarhus

Information Provided By

University of Aarhus

Verification Date

April 2013

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

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