Ignite Creation Date:
2025-12-24 @ 9:54 PM
Ignite Modification Date:
2025-12-25 @ 7:32 PM
Study NCT ID:
NCT01146132
Status:
COMPLETED
Last Update Posted:
2012-10-05
First Post:
2010-06-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Nutrition and Physical Activity in Patients With Cerebrovascular Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 119}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-10-04', 'studyFirstSubmitDate': '2010-06-15', 'studyFirstSubmitQcDate': '2010-06-16', 'lastUpdatePostDateStruct': {'date': '2012-10-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-06-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Differences in mean systolic blood pressure in the two diet/sport arms', 'timeFrame': '4 months', 'description': 'Assess the influence of intensive counselling and of the consumption of red wine on cerebrovascular risk factors, cognition and on surrogate parameters for cerebrovascular disease.'}], 'secondaryOutcomes': [{'measure': 'Effects on cerebrovascular health profile', 'timeFrame': '4 months', 'description': 'Assess effects on cerebrocardiovascular health profile, cognitive function and ultrasound parameters.'}, {'measure': 'Assessment of genetic marker and/or genetic modifications.', 'timeFrame': 'Baseline', 'description': 'The genetic analyses will investigate:\n\nA) Profiles of inflammatory, anti-inflammatory cytokines B) Genes related to risk of stroke C) Chromosome regions related to atherosclerosis D) Genetic polymorphism in inflammation\n\nGenes to be analyzed: FABP2, MTP1, ApoE, ApoA1, PPAR gamma Pro 12 Ala, TNF alpha, Paraoxonase 1, ADH, Kinesin-like protein (KIF) 6 Trp719Arg (rs20455), SNP, 5 (component of complement 5) 2416A\\> G variant (rs17611), sCAMs (sICAM-1, sVCAM-1, sPSEL et sESEL), (C3, C4) Complement and CRP, P-selectin and its ligand, P-selectin glycoprotein ligand 1'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Nutrition', 'Physical activity', 'Cerebrovascular disease', 'wine consumption', 'BMI', 'Pulse transit time', 'transcranial Doppler sonography'], 'conditions': ['Cerebrovascular Disorders']}, 'referencesModule': {'references': [{'pmid': '24228901', 'type': 'DERIVED', 'citation': 'Droste DW, Iliescu C, Vaillant M, Gantenbein M, De Bremaeker N, Lieunard C, Velez T, Meyer M, Guth T, Kuemmerle A, Gilson G, Chioti A. A daily glass of red wine associated with lifestyle changes independently improves blood lipids in patients with carotid arteriosclerosis: results from a randomized controlled trial. Nutr J. 2013 Nov 15;12(1):147. doi: 10.1186/1475-2891-12-147.'}]}, 'descriptionModule': {'briefSummary': 'The study will provide evidence of eating habits and physical activity in cerebrovascular patients in Luxembourg and of the degree to which these habits may be changed acutely (after one month) and in the long run (after 4 months) by intensive counselling. Furthermore the influence of intensive counselling and of the consumption of red wine on cerebrovascular risk factors, cognition, and on surrogate parameters for stroke will be assessed.', 'detailedDescription': 'Quality of life in the elderly and their families is severely affected by stroke and cognitive dysfunction caused by atherosclerosis of the brain supplying arteries. Nutrition, namely a Mediterranean-style diet, nuts, soybean products, whole grain products, dark chocolate, fish oil and avoidance of salt, and regular physical activity play a major role in the prevention of these diseases. Data are available on cardiac patients, however little is known on cerebrovascular patients. The role of red wine in the protection of cerebrovascular disease is discussed; it may be simply an epiphenomenon of otherwise healthy lifestyle in the population with a regularly low alcohol consumption not properly corrected for in epidemiological studies. No prospective randomised data is available.\n\nWe intend to perform a prospective randomised study on nutrition and physical activity in 100 patients with chronic cerebrovascular disease (i.e. patients with atherosclerotic stenosis, at least 20% of a brain supplying artery as demonstrated by carotid ultrasound and without an acute stroke/TIA). The study consists of three parts:\n\n(1) Assessment of eating and physical activity habits in these patients and correlation with indicators of cerebrocardiovascular disease (cerebral perfusion as measured by transcranial Doppler sonography, pulsatility of the transcranial and extracranial Doppler signal, elasticity of the carotid artery, ankle-brachial index, cognitive functioning) and risk factors of cerebrovascular disease (blood pressure and blood pressure amplitude assessed by 24 h ambulatory blood pressure measurement; HDL, LDL, triglycerides, Lp(a), glucose, HbA1c, homocysteine, and fibrinogen; waist-hip ratio and BMI).\n\n2\\) Half of these patients will be randomised to intensive counselling concerning healthy eating and physical activity habits during the first month once a week. All the 100 patients will be reassessed after one month and after 4 months with the above mentioned parameters.\n\n3\\) In a double cross-over design half of the patients allocated to intensive counselling (i.e. n=25) and half of the patients without intensive counselling (n=25) will be allocated to 0,2 l of red wine daily (men) or 0,1l of red wine daily (women), respectively. The remaining 50 patients will be advised to avoid red wine for the time of the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* In- and outpatients of the Neurology Department of the CHL and their family members\n* Carotid atherosclerosis assessed by B-mode ultrasound of at least 20% lumen reduction\n* No acute stroke/TIA/amaurosis fugax (at least 3 months ago)\n* Temporal ultrasound window suitable for recording of the middle cerebral artery\n* Ability to give informed consent\n\nExclusion Criteria:\n\n* No signed informed consent\n* patient not able to give informed consent'}, 'identificationModule': {'nctId': 'NCT01146132', 'acronym': 'ALVINA', 'briefTitle': 'Nutrition and Physical Activity in Patients With Cerebrovascular Disease', 'organization': {'class': 'OTHER', 'fullName': 'Public Research Centre Health, Luxembourg'}, 'officialTitle': 'Nutrition and Physical Activity in Patients With Cerebrovascular Disease', 'orgStudyIdInfo': {'id': 'CRP-Santé'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Luxembourg diet + wine', 'description': 'Luxembourg variant of the mediterranean Diet, physical activity with wine consumption', 'interventionNames': ['Dietary Supplement: Luxembourg variant of Mediterranean diet + physical activity +/- wine']}, {'type': 'OTHER', 'label': 'conventional + wine', 'description': 'conventional Diet with red wine', 'interventionNames': ['Dietary Supplement: Conventional diet +/- wine']}, {'type': 'OTHER', 'label': 'conventional', 'description': 'conventional diet without wine', 'interventionNames': ['Dietary Supplement: Conventional diet +/- wine']}, {'type': 'OTHER', 'label': 'Luxembourg diet', 'description': 'Luxembourg variant of the mediterranean Diet, physical activity with wine consumption', 'interventionNames': ['Dietary Supplement: Luxembourg variant of Mediterranean diet + physical activity +/- wine']}], 'interventions': [{'name': 'Conventional diet +/- wine', 'type': 'DIETARY_SUPPLEMENT', 'description': 'usual eating habits', 'armGroupLabels': ['conventional', 'conventional + wine']}, {'name': 'Luxembourg variant of Mediterranean diet + physical activity +/- wine', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Walnuts, almonds, mustard and soy bean products as part of the Indo-Mediterranean diet could be recommended to ensure a variety of food constellation, as well as dark chocolate. This form of diet will be addressed to as "Luxembourg variant of the Mediterranean diet"', 'armGroupLabels': ['Luxembourg diet', 'Luxembourg diet + wine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1210', 'city': 'Luxembourg', 'country': 'Luxembourg', 'facility': 'CHL', 'geoPoint': {'lat': 49.60982, 'lon': 6.13268}}], 'overallOfficials': [{'name': 'Dirk Droste, Pr, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier du Luxembourg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Manon Gantenbein', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centre Hospitalier du Luxembourg', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Clinical Research Coordinator', 'investigatorFullName': 'Manon Gantenbein', 'investigatorAffiliation': 'Public Research Centre Health, Luxembourg'}}}}