Ignite Creation Date:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2026-03-04 @ 9:54 PM
Study NCT ID:
NCT01242033
Status:
COMPLETED
Last Update Posted:
2010-12-06
First Post:
2010-11-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Acute Red Raspberry Consumption on Post-prandial Oxidative Stress
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-11', 'completionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-12-03', 'studyFirstSubmitDate': '2010-11-08', 'studyFirstSubmitQcDate': '2010-11-12', 'lastUpdatePostDateStruct': {'date': '2010-12-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-11-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in antioxidant capacity from baseline (-0.25 h)', 'timeFrame': '-0.25, 0.25, 0.5, 1, 2, 4 hours post-intake', 'description': "plasma antioxidant capacity measured using the 2,2'-azino-bis(3-ethylbenzthiazoline-6-sulphonic acid) (ABTS) radical cation assay and expressed in Trolox Equivalents (TE)"}], 'secondaryOutcomes': [{'measure': 'change in lipid peroxidation from baseline (-0.25 h)', 'timeFrame': '-0.25, 0.25, 0.5, 1, 2, 4 hours post-intake', 'description': 'serum thiobarbituric acid reactive substances (TBARS) measured as an indicator of the lipid peroxidation product malondialdehyde (MDA)'}, {'measure': 'change in thiols compared to baseline (-0.25 h)', 'timeFrame': '-025, 0.25, 0.5, 1, 2, 4 hours post-intake', 'description': "plasma thiols quantified by 5,5'-dithiobis-(2-nitrobenzoic acid) (DTNB) assay as an indicator of the level of protection against protein oxidation"}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['red raspberries', 'post-prandial', 'oxidative stress', 'antioxidants', 'polyphenols', 'vitamin C', 'acute dietary intervention'], 'conditions': ['Oxidative Stress', 'Antioxidants']}, 'descriptionModule': {'briefSummary': 'Eight healthy adult subjects will be given a meal of one, two or four cups red raspberries, or two slices white bread with or without 200 mg vitamin C, after an overnight fast and consumption of a low polyphenol diet for two days. Blood samples will be taken at various time points over an eight hour period to measure oxidative stress and antioxidant levels in the blood. Each subject will attend 5 study visits with one week intervals and be given each meal in a random order. It is hypothesized that raspberry consumption at higher doses will greater protect against meal-induced oxidative stress compared to bread controls.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy adults\n\nExclusion Criteria:\n\n* blood pressure greater than 120/80 mm Hg\n* body mass index greater than 24.9 kg/m\\^2\n* history of any chronic disease\n* currently taking medications\n* allergy to fruit'}, 'identificationModule': {'nctId': 'NCT01242033', 'briefTitle': 'Effect of Acute Red Raspberry Consumption on Post-prandial Oxidative Stress', 'organization': {'class': 'OTHER', 'fullName': 'University of Toronto'}, 'officialTitle': 'An Acute Intervention Study Investigating the Effect of Red Raspberry Consumption on Post-prandial Oxidative Stress', 'orgStudyIdInfo': {'id': '24774'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'one cup red raspberries', 'description': 'treatment meal consists of one cup red raspberries', 'interventionNames': ['Dietary Supplement: red raspberries']}, {'type': 'EXPERIMENTAL', 'label': 'two cups red raspberries', 'description': 'treatment meal consists of two cups red raspberries', 'interventionNames': ['Dietary Supplement: red raspberries']}, {'type': 'EXPERIMENTAL', 'label': 'four cups red raspberries', 'description': 'treatment meal consists of four cups red raspberries', 'interventionNames': ['Dietary Supplement: red raspberries']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'bread', 'description': 'treatment meal consists of two slices white bread', 'interventionNames': ['Dietary Supplement: bread controls']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'vitamin C', 'description': 'treatment meal consists of two slices white bread and 200 mg vitamin C in the form of supplemental ascorbic acid', 'interventionNames': ['Dietary Supplement: bread controls']}], 'interventions': [{'name': 'red raspberries', 'type': 'DIETARY_SUPPLEMENT', 'description': 'single serving of one, two or four cups red raspberries', 'armGroupLabels': ['four cups red raspberries', 'one cup red raspberries', 'two cups red raspberries']}, {'name': 'bread controls', 'type': 'DIETARY_SUPPLEMENT', 'description': 'two slices white bread alone or with 200 mg vitamin C supplement', 'armGroupLabels': ['bread', 'vitamin C']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5C 2T2', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': "Clinical Nutrition and Risk Factor Modification Centre; St. Michael's Hospital", 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'A V Rao, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Toronto'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Toronto', 'class': 'OTHER'}, 'collaborators': [{'name': 'Unity Health Toronto', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Dr AV Rao, PhD, Professor Emeritus', 'oldOrganization': 'Department of Nutritional Sciences, Faculty of Medicine, University of Toronto'}}}}