Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2026-02-19 @ 2:44 PM
Study NCT ID:
NCT01476033
Status:
COMPLETED
Last Update Posted:
2013-04-10
First Post:
2011-11-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Strong Women Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-04-09', 'studyFirstSubmitDate': '2011-11-16', 'studyFirstSubmitQcDate': '2011-11-17', 'lastUpdatePostDateStruct': {'date': '2013-04-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-11-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Carbonyl groups on protein, oxidized LDL, Malondialdehyde, TNF-alpha, IL-6, Trombelastometry and peripheral microcirculation', 'timeFrame': '6 months', 'description': 'Carbonyl groups on protein as indicators of protein oxidation; oxidized LDL, Malondialdehyde as indicators of Lipidoxidation; TNF-alpha, IL-6 as indicators of inflammation; Trombelastometry: clotting time, thrombocyte ahesion, trombocyte aggregation from whole blood as indicators for blood flow and hemostasis; Peripheral microcirculation in subcutis as indicator for blood flow in peripheral subcutis.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Oxidative stress', 'inflammation', 'blood flow'], 'conditions': ['Oxidative Stress', 'Inflammation']}, 'descriptionModule': {'briefSummary': 'The investigators investigate the impact of an encapsulated fruit, berry and vegetable juice powder concentrate on oxidative stress, inflammation and blood flow before and post exercise in overweight, middle-aged, women.\n\nMain hypotheses (H1):\n\n* The nutraceutical has an impact on oxidative stress reduction.\n* The nutraceutical has an impact on inflammation.\n* The nutraceutical has an impact on blood flow and microcirculation.\n* Walking exercise for 30 minutes has an impact on oxidative stress- and inflammation markers.\n* Walking exercise for 30 minutes has an impact on blood flow and microcirculation\n* The combination of nutraceutical supplementation + walking exercise for 30 minutes has an impact on oxidative stress- and inflammation markers, and on blood flow/microcirculation.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '35 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* women\n* BMI \\> 27\n* praemenopausal\n* non smokers\n* eligibility for exercise\n* 4wk wash out\n\nExclusion Criteria:\n\n* male\n* all people not matching this age group\n* BMI \\> 40 and \\< 27\n* peri- or postmenopausal women\n* smokers\n* all women taking dietary supplements\n* all women that fail in ergometric exercise eligibility testing, refering to the standards in sports medicine (e.g.: significant ST-decrease or increase, blood pressure \\> 240 mmHg, tachycardia, polymorphic extrasystolia, cyanosis, bradyarrhythmia..)\n* Diabetics\n* osteoporosis or osteopenia'}, 'identificationModule': {'nctId': 'NCT01476033', 'briefTitle': 'Strong Women Study', 'organization': {'class': 'OTHER', 'fullName': 'Green Beat'}, 'officialTitle': 'Impact of Encapsulated Fruit, Berry and Vegetable Juice Powder Concentrate on Oxidative Stress, Inflammation and Blood Flow Before and Post Exercise in Overweight, Middle-aged, Women.', 'orgStudyIdInfo': {'id': '23-508 ex 10/11'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'fruit, berry and vegetable concentrate', 'description': '20 ladies receive an encapsulated, powdered fruit, berry and vegetable concentrate for 8 weeks', 'interventionNames': ['Dietary Supplement: nutraceutical group']}, {'type': 'PLACEBO_COMPARATOR', 'label': '20 women with placebo', 'description': 'placebo for 8 weeks', 'interventionNames': ['Dietary Supplement: nutraceutical group']}], 'interventions': [{'name': 'nutraceutical group', 'type': 'DIETARY_SUPPLEMENT', 'description': '6 capsules of supplement or placebo for 8wk', 'armGroupLabels': ['20 women with placebo', 'fruit, berry and vegetable concentrate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8010', 'city': 'Graz', 'country': 'Austria', 'facility': 'Medical University of Graz', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}], 'overallOfficials': [{'name': 'Manfred Lamprecht, PhD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of Graz'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Green Beat', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Lamprecht Manfred PhD, PhD', 'investigatorAffiliation': 'Green Beat'}}}}