Long-term Investigation of Resveratrol in Obesity

Obesity Clinical Trial

— LIRMOI  

Official title:

Long-term Investigation of Resveratrol on Management of Metabolic Syndrome, Osteoporosis and Inflammation, and Identification of Plant Derived Anti-inflammatory Compounds

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01412645
• Other study ID #: LIRMOI
• Status: Completed
• Phase: N/A
• First received: July 13, 2011
• Last updated: December 12, 2013
• Start date: August 2011
• Est. completion date: August 2013

Study information

• Verified date: December 2013
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 30 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Inflammation
• Insulin Resistance
• Insulin Sensitivity
• Obesity
• Osteoporosis

Intervention

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

Locations

Country	Name	City	State
Denmark	Clinical Institute, Aarhus University	Aarhus

Sponsors (3)

Lead Sponsor	Collaborator
University of Aarhus	Central Denmark Region, The Ministry of Science, Technology and Innovation, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes from Baseline in markers of inflammation (hs-CRP) in blood after 4 months of treatment with either resveratrol or placebo		4 months	No

External Links

•   Official web page for the LIRMOI projekt, background info and contact