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Long-term Investigation of Resveratrol in Obesity (LIRMOI)

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ClinicalTrials.gov Identifier: NCT01412645
Recruitment Status : Completed
First Posted : August 9, 2011
Last Update Posted : December 13, 2013
Sponsor:
Collaborators:
Information provided by (Responsible Party):

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
Obesity Inflammation Insulin Sensitivity Osteoporosis Dietary Supplement: Resveratrol

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  (Clinical Trial)
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 : August 2011
Primary Completion Date : August 2013
Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Resveratrol
U.S. FDA Resources

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 [ Time Frame: 4 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01412645


Locations
Denmark
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
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01412645     History of Changes
Other Study ID Numbers: LIRMOI
First Posted: August 9, 2011    Key Record Dates
Last Update Posted: December 13, 2013
Last Verified: December 2013

Keywords provided by University of Aarhus:
Obesity
Inflammation
Metabolic Syndrome
Insulin sensitivity
Osteoporosis
Bone turnover
Ectopic fat accumulation
Resveratrol

Additional relevant MeSH terms:
Resveratrol
Obesity
Inflammation
Osteoporosis
Hypersensitivity
Insulin Resistance
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Pathologic Processes
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Immune System Diseases
Hyperinsulinism
Glucose Metabolism Disorders
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Antioxidants