NCT01150955

Brief Summary

We want to investigate whether the food supplement resveratrol is able to counteract the detrimental effects of obesity.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 24, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 25, 2010

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2010

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

March 22, 2012

Status Verified

March 1, 2012

Enrollment Period

1.1 years

First QC Date

June 24, 2010

Last Update Submit

March 21, 2012

Conditions

Metabolic SyndromeObesity

Keywords

ResveratrolDiabetesSIRT1STAT5IGF-IGrowth hormoneNAFLDLongevitySubstrate metabolismCalorie restriction

Outcome Measures

Primary Outcomes (1)

  • Metabolic parameters

    Regarding glucose, protein and fat metabolism.

    Five weeks

Secondary Outcomes (1)

  • Pathways of substrate metabolism.

    Five weeks

Study Arms (2)

Resveratrol

ACTIVE COMPARATOR

Dietary supplement of resveratrol 500 mg three times a day over five weeks.

Dietary Supplement: Resveratrol

Placebo

PLACEBO COMPARATOR
Other: Placebo

Interventions

ResveratrolDIETARY_SUPPLEMENT

500 mg three times a day for five weeks.

Also known as: Fluxome Sciences.
Resveratrol
PlaceboOTHER

Placebo (starch capsules) 500 mg three times a day for five weeks.

Also known as: Starch
Placebo

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI \> 30 kg/m2
  • Otherwise healthy
  • Written informed consent

You may not qualify if:

  • Any disease
  • Alcohol dependency
  • Allergy to trial medication
  • Present or previous malignancy
  • Participation in other clinical trials within three months before randomization

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital, Department of Endocrinology, MEA

Aarhus, 8000, Denmark

Location

Related Publications (2)

  • Clasen BF, Poulsen MM, Escande C, Pedersen SB, Moller N, Chini EN, Jessen N, Jorgensen JO. Growth hormone signaling in muscle and adipose tissue of obese human subjects: associations with measures of body composition and interaction with resveratrol treatment. J Clin Endocrinol Metab. 2014 Dec;99(12):E2565-73. doi: 10.1210/jc.2014-2215.

    PMID: 25050904DERIVED

  • Poulsen MM, Vestergaard PF, Clasen BF, Radko Y, Christensen LP, Stodkilde-Jorgensen H, Moller N, Jessen N, Pedersen SB, Jorgensen JO. High-dose resveratrol supplementation in obese men: an investigator-initiated, randomized, placebo-controlled clinical trial of substrate metabolism, insulin sensitivity, and body composition. Diabetes. 2013 Apr;62(4):1186-95. doi: 10.2337/db12-0975. Epub 2012 Nov 28.

    PMID: 23193181DERIVED

MeSH Terms

Conditions

Metabolic SyndromeObesityDiabetes MellitusNon-alcoholic Fatty Liver Disease

Interventions

ResveratrolStarch

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsEndocrine System DiseasesFatty LiverLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

StilbestrolsStilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolyphenolsPhenolsGlucansBiopolymersPolymersMacromolecular SubstancesDietary CarbohydratesCarbohydratesPolysaccharides

Study Officials

  • Jens Otto L Jørgensen, Professor,MD

    Aarhus University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2010

First Posted

June 25, 2010

Study Start

October 1, 2010

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

March 22, 2012

Record last verified: 2012-03

Locations

DK(1)