LIRMOI: Long-term Investigation of Resveratrol in Obesity

• Sponsor: University of Aarhus (Other)
• Overall Status: Completed
• CT.gov ID: NCT01412645
• Collaborator: The Ministry of Science, Technology and Innovation, Denmark (Other), Central Denmark Region (Other)
• Enrollment: 76
• Location: 1
• Arms: 3
• Duration (Months): 24
• Patients Per Site Per Month: 3.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity; Inflammation; Insulin Sensitivity; Osteoporosis	Dietary Supplement: Resveratrol	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 76 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Basic Science
• Official Title: Long-term Investigation of Resveratrol on Management of Metabolic Syndrome, Osteoporosis and Inflammation, and Identification of Plant Derived Anti-inflammatory Compounds
• Study Start Date: Aug 1, 2011
• Actual Primary Completion Date: Aug 1, 2013
• Actual Study Completion Date: Aug 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo	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
Experimental: High-dose Resveratrol	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
Experimental: Low-dose Resveratrol	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

Outcome Measures

Primary Outcome Measures

1. Changes from Baseline in markers of inflammation (hs-CRP) in blood after 4 months of treatment with either resveratrol or placebo [4 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 60 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Institute, Aarhus University	Aarhus		Denmark	8000

Sponsors and Collaborators

• University of Aarhus
• The Ministry of Science, Technology and Innovation, Denmark
• Central Denmark Region

Investigators

• Principal Investigator: Steen B Pedersen, MD, PhD, University of Aarhus

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Aarhus
• ClinicalTrials.gov Identifier: NCT01412645
• Other Study ID Numbers: LIRMOI
• First Posted: Aug 9, 2011
• Last Update Posted: Dec 13, 2013
• Last Verified: Dec 1, 2013

• Keywords provided by University of Aarhus: Obesity; Inflammation; Metabolic Syndrome; Insulin sensitivity; Osteoporosis; Bone turnover; Ectopic fat accumulation; Resveratrol
• Additional relevant MeSH terms: Osteoporosis; Obesity; Insulin Resistance; Hypersensitivity; Inflammation; Resveratrol

Study Results

No Results Posted as of Dec 13, 2013