Ignite Creation Date:
2025-12-24 @ 9:48 PM
Ignite Modification Date:
2026-02-20 @ 5:58 PM
Study NCT ID:
NCT02245932
Status:
COMPLETED
Last Update Posted:
2019-05-17
First Post:
2014-09-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Resveratrol In Chronic Obstructive Pulmonary Disease (COPD) Patients (CARMENS-trial)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077185', 'term': 'Resveratrol'}, {'id': 'D036881', 'term': 'Long-Term Synaptic Depression'}], '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'}, {'id': 'D009473', 'term': 'Neuronal Plasticity'}, {'id': 'D009424', 'term': 'Nervous System Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2017-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-16', 'studyFirstSubmitDate': '2014-09-16', 'studyFirstSubmitQcDate': '2014-09-18', 'lastUpdatePostDateStruct': {'date': '2019-05-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-09-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Medical history', 'timeFrame': '0 and 4 weeks', 'description': 'Medication use'}, {'measure': 'Physical activity', 'timeFrame': '0 and 4 weeks', 'description': 'Assessed by:\n\n* Accelerometry\n* Short Questionnaire to Assess Health (SQUASH)'}, {'measure': 'Severity of dyspnea and COPD', 'timeFrame': '0 and 4 weeks', 'description': 'Assessed by:\n\n* Medical Research Council scale (MRC-scale)\n* COPD assessment test (CAT)\n* Clinical COPD Questionnaire (CCQ)'}, {'measure': 'Sleep pattern', 'timeFrame': '0 and 4 weeks', 'description': 'Assess by Pittburgh Sleep Quality Index (PSQI)'}, {'measure': 'Food intake', 'timeFrame': '0 and 4 weeks', 'description': 'Assessed by food anamnesis questionnaire'}, {'measure': 'Resveratrol and dihydroresveratrol concentrations', 'timeFrame': '0 and 4 weeks', 'description': 'Assessed by blood sampling'}, {'measure': 'Electrocardiogram', 'timeFrame': '0 and 4 weeks', 'description': 'Measured with a ECG'}, {'measure': 'Safety parameters', 'timeFrame': '0 and 4 weeks', 'description': 'Assessed in blood:\n\n* Creatinine\n* Urea\n* Sodium\n* Potassium\n* Gamma-GT\n* ALAT\n* ASAT\n* Alkaline Phosphatase'}, {'measure': 'Baseline lung function', 'timeFrame': '0 weeks', 'description': 'Assessed by spirometry'}], 'primaryOutcomes': [{'measure': 'Change in mitochondrial function', 'timeFrame': '0 and 4 weeks', 'description': 'Assessed by measuring mitochondrial respiration (using the oxygraph) of a muscle biopsy of the quadriceps muscle (vastus lateralis)'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in high sensitivity systemic inflammation (CRP) at 4 weeks', 'timeFrame': '0 and 4 weeks', 'description': 'High sensitivity C-reactive protein (CRP) as a clinical marker of systemic inflammation via blood sampling.'}, {'measure': 'Change in adipose tissue inflammation', 'timeFrame': '0 and 4 weeks', 'description': 'Assessed by adipose tissue biopsy'}, {'measure': 'Change in systematic inflammatory profile', 'timeFrame': '0 and 4 weeks', 'description': 'Assessed via blood sampling'}, {'measure': 'Change in lipid profile', 'timeFrame': '0 and 4 weeks', 'description': 'Assessed via blood sampling'}, {'measure': 'Change in insulin sensitivity', 'timeFrame': '0 and 4 weeks', 'description': 'Assessed by HOMA-IR'}, {'measure': 'Change in body composition', 'timeFrame': '0 and 4 weeks', 'description': 'Assessed by:\n\n* DEXA-scan\n* Anthropometric measurements'}, {'measure': 'Change in quadriceps function', 'timeFrame': '0 and 4weeks', 'description': 'Assessed by leg dynamometry (Biodex)'}, {'measure': 'Change in blood pressure', 'timeFrame': '0 and 4 weeks', 'description': 'Measured with a hematometer'}, {'measure': 'Change in heart rate', 'timeFrame': '0 and 4 weeks', 'description': 'Measured with a hematometer'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Pulmonary disease, Chronic Obstructive', 'Cardiovascular diseases', 'Metabolism', 'Resveratrol'], 'conditions': ['Pulmonary Disease, Chronic Obstructive']}, 'referencesModule': {'references': [{'pmid': '22055504', 'type': 'BACKGROUND', 'citation': 'Timmers S, Konings E, Bilet L, Houtkooper RH, van de Weijer T, Goossens GH, Hoeks J, van der Krieken S, Ryu D, Kersten S, Moonen-Kornips E, Hesselink MKC, Kunz I, Schrauwen-Hinderling VB, Blaak E, Auwerx J, Schrauwen P. Calorie restriction-like effects of 30 days of resveratrol supplementation on energy metabolism and metabolic profile in obese humans. Cell Metab. 2011 Nov 2;14(5):612-22. doi: 10.1016/j.cmet.2011.10.002.'}, {'pmid': '23281350', 'type': 'BACKGROUND', 'citation': 'van den Borst B, Gosker HR, Schols AM. Central fat and peripheral muscle: partners in crime in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2013 Jan 1;187(1):8-13. doi: 10.1164/rccm.201208-1441OE. No abstract available.'}, {'pmid': '31996311', 'type': 'DERIVED', 'citation': 'Beijers RJ, Gosker HR, Sanders KJ, de Theije C, Kelders M, Clarke G, Cryan JF, van den Borst B, Schols AM. Resveratrol and metabolic health in COPD: A proof-of-concept randomized controlled trial. Clin Nutr. 2020 Oct;39(10):2989-2997. doi: 10.1016/j.clnu.2020.01.002. Epub 2020 Jan 13.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective is to investigate the efficacy of resveratrol on mitochondrial function in patients with COPD. The secondary objective is to investigate the effect of resveratrol on body composition, inflammatory status and mechanistic markers in blood, adipose and muscle tissue as well as a comprehensive assessment of metabolicand physical performance profile known to be affected by resveratrol.', 'detailedDescription': 'Rationale: Patients with COPD are often chaacterized by disturbed metabolic health affecting physical and cognitive function, which is reflected in altered body composition. current studies in healthy subjects suggest that resveratrol improves metabolic health by enhancing muscle mitochondrial function and adipose tissue morphology.\n\nStudy design: Proof-of-concept randomized placebo-controlled double blinded clinical trial of 4 weeks.\n\nNature and extent of the burden and risks associated with participation, benefit and group relatedness: Subjects may be confronted with certain inconveniences and risks. Subjects will be asked to wear an accelerometer two times for one week. During the entire study period subjects will visit the MUMC+ 2 times for various non-invasive measurements (questionnaires, anthropometry, and physical function test) as well as some minor invasive procedures (venous blood sampling and muscle and fat biopsies) which can cause a local haematoma afterwards. However, the patients will be informed about their metabolic and cardiovascular health, which we expect to be positively affected by the intervention. In addition, all patients will receive a lifestyle advice tailored to their health status.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* COPD patients\n* Current or ex-smoker\n* Age \\>18 years\n\nExclusion Criteria:\n\n* COPD patients planned for pulmonary rehabilitation or who recently participated in a rehabilitation program in the previous 6 months\n* Investigator's uncertainty about willingness or ability of the patient to comply with the protocol requirements\n* Participation in any other study involving investigational exercise training, nutritional or pharmacological intervention\n* Oral glucocorticoid use\n* Recent exacerbation (\\<4 weeks) that required oral steroids and/or hospital admission\n* Subject is pregnant, planning to be pregnant during the study period, lactating, or women who consider themselves to be of childbearing potential and who are engaged in an active sex life and are unwilling to commit to the use of an approved form of contraception throughout the study period. The method of contraception must be recorded in the source documentation;\n* Diabetes mellitus (all types), active cardiovascular disease or a cardiovascular event (such as myocardial infarction, cerebrovascular haemorrhage/infarction) in the previous 6 months, recent major surgery, thyroid dysfunction, hepatic or renal disorders, current malignancy (except for dermal malignancies) or central or obstructive sleep apnea;\n* Current alcohol consumption \\> 20 grams alcohol/day;\n* Intake of resveratrol containing dietary supplements."}, 'identificationModule': {'nctId': 'NCT02245932', 'acronym': 'CARMENS', 'briefTitle': 'Resveratrol In Chronic Obstructive Pulmonary Disease (COPD) Patients (CARMENS-trial)', 'organization': {'class': 'OTHER', 'fullName': 'Maastricht University Medical Center'}, 'officialTitle': 'The Effect of Resveratrol on Metabolism and Cardiovascular Risk Profile in Patients With Chronic Obstructive Pulmonary Disease (COPD)', 'orgStudyIdInfo': {'id': '143031'}, 'secondaryIdInfos': [{'id': '3.4.12.023', 'type': 'OTHER_GRANT', 'domain': 'The Netherlands Lung Foundation'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Resveratrol supplementation', 'description': '150 mg of resveratrol for 4 weeks (split over two doses of 75 mg/day)', 'interventionNames': ['Dietary Supplement: Resveratrol']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo supplementation', 'description': 'Placebo for 4 weeks (split over two doses per day)', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Resveratrol', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['resVida (99% pure trans-resveratrol) provided by DSM Nutritional Products, Ltd.'], 'description': '4 weeks of 150 mg resveratrol (2 times 75mg/day)', 'armGroupLabels': ['Resveratrol supplementation']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': '4 weeks of placebo supplementation (two doses per day)', 'armGroupLabels': ['Placebo supplementation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Maastricht', 'state': 'Limburg', 'country': 'Netherlands', 'facility': 'Maastricht University Medical Center', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}], 'overallOfficials': [{'name': 'Annemie Schols, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maastricht University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maastricht University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Netherlands Asthma Foundation', 'class': 'OTHER'}, {'name': 'DSM Nutritional Products, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}