Long-term Investigation of Resveratrol in Obesity (LIRMOI)

This study has been completed.
Sponsor:
Collaborators:
The Ministry of Science, Technology and Innovation, Denmark
Central Denmark Region
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01412645
First received: July 13, 2011
Last updated: December 12, 2013
Last verified: December 2013
  Purpose

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 Intervention
Obesity
Inflammation
Insulin Sensitivity
Osteoporosis
Dietary Supplement: Resveratrol

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • 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 ]

Enrollment: 76
Study Start Date: August 2011
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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.

  Eligibility

Ages Eligible for Study:   30 Years to 60 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional Information:
No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01412645     History of Changes
Other Study ID Numbers: LIRMOI
Study First Received: July 13, 2011
Last Updated: December 12, 2013
Health Authority: Denmark: Ethics Committee

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

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

ClinicalTrials.gov processed this record on August 28, 2014