Clinical trial NCT01412645: Long-term Investigation of Resveratrol in Obesity
Official title: Long-term Investigation of Resveratrol on Management of Metabolic Syndrome, Osteoporosis and Inflammation, and Identification of Plant Derived Anti-inflammatory Compounds
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Inflammation
Insulin Sensitivity
Osteoporosis
Keywords: Obesity
Inflammation
Metabolic Syndrome
Insulin sensitivity
Osteoporosis
Bone turnover
Ectopic fat accumulation
Resveratrol
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: The Ministry of Science, Technology and Innovation, Denmark
name: Central Denmark Region
First posted: 2011-08-09
Enrollment: 76
Sex: MALE
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility 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

Primary outcomes:
measure: Changes from Baseline in markers of inflammation (hs-CRP) in blood after 4 months of treatment with either resveratrol or placebo
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Clinical Institute, Aarhus University
Study officials:
affiliation: University of Aarhus
name: Steen B Pedersen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kjaer TN, Ornstrup MJ, Poulsen MM, Stodkilde-Jorgensen H, Jessen N, Jorgensen JOL, Richelsen B, Pedersen SB. No Beneficial Effects of Resveratrol on the Metabolic Syndrome: A Randomized Placebo-Controlled Clinical Trial. J Clin Endocrinol Metab. 2017 May 1;102(5):1642-1651. doi: 10.1210/jc.2016-2160.
citation: Ornstrup MJ, Harslof T, Kjaer TN, Langdahl BL, Pedersen SB. Resveratrol increases bone mineral density and bone alkaline phosphatase in obese men: a randomized placebo-controlled trial. J Clin Endocrinol Metab. 2014 Dec;99(12):4720-9. doi: 10.1210/jc.2014-2799.