Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2026-02-25 @ 4:56 PM
Study NCT ID:
NCT00998504
Status:
COMPLETED
Last Update Posted:
2011-03-18
First Post:
2009-10-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
resVida and Fat Oxidation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D028361', 'term': 'Mitochondrial Diseases'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077185', 'term': 'Resveratrol'}], 'ancestors': [{'id': 'D000081225', 'term': 'Stilbestrols'}, {'id': 'D013267', 'term': 'Stilbenes'}, {'id': 'D001597', 'term': 'Benzylidene Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D059808', 'term': 'Polyphenols'}, {'id': 'D010636', 'term': 'Phenols'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-03', 'completionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-03-17', 'studyFirstSubmitDate': '2009-10-19', 'studyFirstSubmitQcDate': '2009-10-19', 'lastUpdatePostDateStruct': {'date': '2011-03-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-10-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'difference in fat oxidation between resVida and placebo treated group', 'timeFrame': '9 months'}], 'secondaryOutcomes': [{'measure': 'difference in mitochondrial biogenesis, function, and lipolysis in adipose and skeletal muscle tissue between resVida and placebo treated group', 'timeFrame': '9 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['impaired fat oxidation', 'fat accumulation', 'mitochondrial dysfunction', 'mitochondrial biogenesis'], 'conditions': ['Obesity']}, 'referencesModule': {'references': [{'pmid': '23663119', 'type': 'DERIVED', 'citation': 'Knop FK, Konings E, Timmers S, Schrauwen P, Holst JJ, Blaak EE. Thirty days of resveratrol supplementation does not affect postprandial incretin hormone responses, but suppresses postprandial glucagon in obese subjects. Diabet Med. 2013 Oct;30(10):1214-8. doi: 10.1111/dme.12231. Epub 2013 Jun 7.'}]}, 'descriptionModule': {'briefSummary': 'There is now a general consensus that the combination of excessive energy intake and a low capacity to oxidize fat will lead to muscular fat accumulation and insulin resistance. It is known for many years that physical exercise is the most powerful treatment to combat insulin resistance, but it is also known that it is difficult to get people to exercise. A major breakthrough has come from the nutrition field, with the finding that resveratrol, a natural polyphenolic compound, could serve as an "exercise mimetic" by protecting mice from many detrimental effects of diet-induced obesity. Therefore the researchers would like to investigate if resVida can increase skeletal muscle mitochondrial function and fat oxidative capacity in obese subjects. The researchers hypothesize that an increased mitochondrial function together with an increased intrinsic activity will lead to a better control of fatty acid handling in muscle, upon a high-fat challenge.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '45 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* male sex\n* age 45-65 years\n* body fat percentage \\> 25%, BMI 30-35 kg/m2\n* sedentary\n* stable dietary habits\n* willingness to abstain from ingestion of resveratrol-containing foods\n* healthy\n\nExclusion Criteria:\n\n* female sex\n* unstable body weight (weight gain or loss \\> 3 kg in the last three months)\n* total body fat percentage \\< 25%\n* fasting plasma glucose \\> 6.1 mmol/l\n* hemoglobin \\< 7.8 mmol/l\n* engagement in programmed exercise \\> 2 hours total per week\n* impaired kidney and/ or liver function\n* first- or second-degree family member with type 2 diabetes mellitus\n* any medical condition requiring treatment and/ or medication use\n* intake of dietary supplements except vitamins and minerals\n* unwilling to restrict high-resveratrol containing foods\n* current alcohol consumption \\> 20 grams/day\n* participation in another biomedical study within 1 month before the screening visit\n* a contraindication to MRI scanning. These contraindications include patients with the following devices:\n* central nervous system aneurysm clips\n* implanted neural stimulator\n* implanted cardiac pacemaker or defibrillator\n* cochlear implant\n* insulin pump\n* or metal containing corpora aliena in the eye or brains'}, 'identificationModule': {'nctId': 'NCT00998504', 'briefTitle': 'resVida and Fat Oxidation', 'organization': {'class': 'OTHER', 'fullName': 'Maastricht University Medical Center'}, 'officialTitle': 'Effect of resVida on Fat Oxidation and Mitochondrial Biogenesis in Healthy Obese Subjects', 'orgStudyIdInfo': {'id': 'MEC 09-3-039'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'starch pill', 'interventionNames': ['Dietary Supplement: placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'resVida', 'description': 'synthetic pill containing 75 mg of resveratrol', 'interventionNames': ['Dietary Supplement: resVida']}], 'interventions': [{'name': 'resVida', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['resveratrol'], 'description': 'resVida or placebo will be given for 30 days, twice daily. One pill, which contains 75 mg of resVida, will be provided with lunch, and the other pill will be provided with diner. So in total, 150 mg/day will be given.', 'armGroupLabels': ['resVida']}, {'name': 'placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'resVida or placebo will be given for 30 days, twice daily. One pill, which contains 75 mg of resVida, will be provided with lunch, and the other pill will be provided with diner. So in total, 150 mg/day will be given.', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6200 MD', 'city': 'Maastricht', 'state': 'Limburg', 'country': 'Netherlands', 'facility': 'Maastricht University Medical Center', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}], 'overallOfficials': [{'name': 'Silvie Timmers, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maastricht UMC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maastricht University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'DSM Nutritional Products, Inc.', 'class': 'INDUSTRY'}, {'name': 'Top Institute Food and Nutrition', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Silvie Timmers, MSc', 'oldOrganization': 'Top Institute Food and Nutrition'}}}}