Ignite Creation Date:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2025-12-26 @ 2:13 AM
Study NCT ID:
NCT00756405
Status:
COMPLETED
Last Update Posted:
2023-02-22
First Post:
2008-09-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Dietary Antioxidants on Cardiovascular Risk Factors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D006973', 'term': 'Hypertension'}], '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': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 88}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-18', 'studyFirstSubmitDate': '2008-09-19', 'studyFirstSubmitQcDate': '2008-09-19', 'lastUpdatePostDateStruct': {'date': '2023-02-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-09-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in inflammatory Markers [monocyte chemotactic protein-1 (MCP-1), interleukin-6 (IL-6), and soluble intercellular adhesion molecule-1 (sICAM-1)] at 8 weeks', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Change was calculated as the value at 8 weeks minus the value at baseline'}], 'secondaryOutcomes': [{'measure': 'Blood concentrations of antioxidants at baseline and 8 weeks', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Blood concentrations of carotenoids, tocopherols, selenium, and vitamin C (to validate dietary change)'}, {'measure': 'Dietary antioxidants', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Dietary intake of carotenoids, tocopherols, selenium, and vitamin C (as measured by 3-day dietary recalls)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Adults', 'Antioxidants', 'Inflammatory markers', 'Diet', 'Supplements'], 'conditions': ['Obesity', 'Hyperlipidemia', 'Hypertension']}, 'referencesModule': {'references': [{'pmid': '29540273', 'type': 'BACKGROUND', 'citation': 'Dewell A, Tsao P, Rigdon J, Gardner CD. Antioxidants from diet or supplements do not alter inflammatory markers in adults with cardiovascular disease risk. A pilot randomized controlled trial. Nutr Res. 2018 Feb;50:63-72. doi: 10.1016/j.nutres.2017.10.017. Epub 2017 Nov 2.'}], 'seeAlsoLinks': [{'url': 'https://med.stanford.edu/nutrition/research/completed-studies/dietary-antioxidants.html', 'label': 'Study description and results.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the Antioxidant Study was to compare the efficacy of foods naturally rich in antioxidants with that of antioxidants in a pill form on markers of inflammation and plasma cholesterol in healthy adults at risk of cardiovascular disease.', 'detailedDescription': 'Increasing the amount of antioxidants in your diet is thought to be one way to improve your health. If antioxidants do have a beneficial effect, one way to measure that is to examine possible changes in the levels of inflammatory markers in your blood.\n\nParticipants were asked to consume an antioxidant supplement including carotenoids, mixed tocopherols, vitamin C and selenium, or a placebo for 8 weeks. The doses of antioxidants will be similar to the amounts suggested by the United States Department of Agriculture (USDA) recommended daily allowances (RDA). In addition, a group of participants will be asked to change their usual eating habits and consume more of certain foods that are naturally good sources of the four antioxidants contained in the pills.\n\nEligible participants were asked to come to the Stanford Campus for 3 fasting blood draws over the period of 8 weeks and to complete diet and physical activity questionnaires at the beginning, middle, and end of the study period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:Overweight/obesity; high LDL cholesterol, pre-hypertension.\n\nExclusion Criteria:1. Daily intake of \\> 5 servings of vegetables and fruits 2. Fasting blood glucose \\>140 mg/dL 3. BMI \\>40 4. Liver or renal disease; Atherosclerosis (e.g., CAD, PAD); Malignant neoplasm; Ongoing infection; Inflammatory disease 5.Currently taking the following medications: Anti-inflammatory drugs Lipid lowering drugs Anti-hypertensive drugs Calcium containing drugs Drugs known to affect blood coagulation Drugs known to affect antioxidant status 6. Pregnant or lactating 7. Inability to communicate effectively with study staff'}, 'identificationModule': {'nctId': 'NCT00756405', 'briefTitle': 'Effects of Dietary Antioxidants on Cardiovascular Risk Factors', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Potential Health Benefits of Dietary Antioxidants From Supplements v. Foods', 'orgStudyIdInfo': {'id': 'SU-08202008-1284'}, 'secondaryIdInfos': [{'id': '1R21AT003245-01', 'link': 'https://reporter.nih.gov/quickSearch/1R21AT003245-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Diet Group', 'description': 'Increased antioxidant diet and placebo pill.', 'interventionNames': ['Behavioral: Antioxidant diet', 'Dietary Supplement: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Supplement Group', 'description': 'Usual diet and antioxidant supplement.', 'interventionNames': ['Dietary Supplement: Antioxidant supplement']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Usual diet and placebo pill.', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Antioxidant diet', 'type': 'BEHAVIORAL', 'description': 'Participants were asked to increase antioxidant-rich food intake to approximately double their daily habitual intake and take a placebo pill.', 'armGroupLabels': ['Diet Group']}, {'name': 'Antioxidant supplement', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Participants were asked to consume their usual diet and take a supplement containing carotenoids, mixed tocopherols, vitamin C and selenium, designed to approximately double their daily habitual intake.', 'armGroupLabels': ['Supplement Group']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Participants were asked to consume their usual diet and take a placebo pill.', 'armGroupLabels': ['Diet Group', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University School of Medicine', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'overallOfficials': [{'name': 'Christopher D Gardner', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Christopher Gardner', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Center for Complementary and Integrative Health (NCCIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine (Research)', 'investigatorFullName': 'Christopher Gardner', 'investigatorAffiliation': 'Stanford University'}}}}