Ignite Creation Date:
2025-12-24 @ 7:06 PM
Ignite Modification Date:
2025-12-25 @ 5:54 PM
Study NCT ID:
NCT01591057
Status:
COMPLETED
Last Update Posted:
2012-11-27
First Post:
2012-04-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Fruit and Vegetable Intake on Markers of Fruit and Vegetable Consumption
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': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-11-22', 'studyFirstSubmitDate': '2012-04-27', 'studyFirstSubmitQcDate': '2012-05-02', 'lastUpdatePostDateStruct': {'date': '2012-11-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-05-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in biomarkers of fruit and vegetable consumption', 'timeFrame': 'Baseline and 4 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['fruit', 'vegetables', 'biomarkers', 'randomised controlled feeding study', 'Fruit and vegetable intake biomarkers in healthy adults'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '29490640', 'type': 'DERIVED', 'citation': 'Appleton KM, McGrath AJ, McKinley MC, Draffin CR, Hamill LL, Young IS, Woodside JV. The value of facial attractiveness for encouraging fruit and vegetable consumption: analyses from a randomized controlled trial. BMC Public Health. 2018 Mar 1;18(1):298. doi: 10.1186/s12889-018-5202-6.'}, {'pmid': '26081648', 'type': 'DERIVED', 'citation': 'McGrath AJ, Hamill LL, Cardwell CR, Draffin CR, Neville CE, Appleton KM, McEneny J, McKinley MC, Young IS, Woodside JV. Combining vitamin C and carotenoid biomarkers better predicts fruit and vegetable intake than individual biomarkers in dietary intervention studies. Eur J Nutr. 2016 Jun;55(4):1377-88. doi: 10.1007/s00394-015-0953-7. Epub 2015 Jun 17.'}]}, 'descriptionModule': {'briefSummary': "This study will examine what contribution of 'markers' of fruit and vegetable (FV) intake in blood and urine is most closely related to FV intake. 30 healthy volunteers will be fed either 2, 5 or 8 portions of FV per day for 4 weeks (ten participants per group, randomly assigned). Volunteers will have all their food provided during the study, and will consume two meals each weekday at the University. Volunteers will complete diet and lifestyle questionnaires at the start and end of the study and will have blood and urine samples collected at 0, 2 and 4 weeks.", 'detailedDescription': 'Single biomarkers of FV consumption, such as Vitamin C and certain carotenoids and flavonoids, have been proposed, but associations between these compounds and FV intake are relatively weak. The investigators propose that, given the complexity of FV, production of an algorithm based on a wide variety of bioactive compounds found in FV might better predict FV consumption. A controlled feeding study (30 volunteers randomised to 2, 5 or 8 portions of FV day for 4 weeks) will allow development of such an algorithm. Volunteers will be recruited by advertisement from QUB and the general public, and will have all their food provided for the 4 week period (two meals per day during the week to be consumed under supervision at the University).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-65 years\n* Usual consumption of fruit and vegetables \\<= 2 portions/day\n\nExclusion Criteria:\n\n* Use of any high dose vitamin, mineral or dietary supplements\n* Current smoker\n* BMI \\> 35 kg/m2\n* Inability to provide informed consent\n* Excessive alcohol consumption (\\>28 Units/week men or \\>21 Units/week women)\n* Food sensitivities or allergies that would interfere with a tolerance of a fruit and vegetable rich diet\n* Medical conditions or dietary restrictions that would substantially limit inability to complete the study requirements'}, 'identificationModule': {'nctId': 'NCT01591057', 'acronym': 'BIOFAV', 'briefTitle': 'Effect of Fruit and Vegetable Intake on Markers of Fruit and Vegetable Consumption', 'organization': {'class': 'OTHER', 'fullName': "Queen's University, Belfast"}, 'officialTitle': 'Effect of Increased Fruit and Vegetable Intake on Biomarkers of Fruit and Vegetable Consumption', 'orgStudyIdInfo': {'id': '11/07'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '2 Portions', 'interventionNames': ['Dietary Supplement: 2 portions of fruit and vegetables per day']}, {'type': 'EXPERIMENTAL', 'label': '5 portions', 'interventionNames': ['Dietary Supplement: 5 portions of fruit and vegetables per day']}, {'type': 'EXPERIMENTAL', 'label': '8 portions', 'interventionNames': ['Dietary Supplement: 8 portions of fruit and vegetables per day']}], 'interventions': [{'name': '2 portions of fruit and vegetables per day', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['2 portions/day'], 'description': 'Consume 2 portions of fruit and vegetables per day', 'armGroupLabels': ['2 Portions']}, {'name': '5 portions of fruit and vegetables per day', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['5 portions/day'], 'description': 'Consume 5 portions of fruit and vegetables per day', 'armGroupLabels': ['5 portions']}, {'name': '8 portions of fruit and vegetables per day', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['8 portions/day'], 'description': 'Consume 8 portions of fruit and vegetables per day', 'armGroupLabels': ['8 portions']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'BT12 6BJ', 'city': 'Belfast', 'country': 'United Kingdom', 'facility': "Queen's University Belfast", 'geoPoint': {'lat': 54.59682, 'lon': -5.92541}}], 'overallOfficials': [{'name': 'Jayne V Woodside, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Queen's University, Belfast"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Queen's University, Belfast", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Reader in Clinical Biochemistry', 'investigatorFullName': 'Jayne Woodside, PhD', 'investigatorAffiliation': "Queen's University, Belfast"}}}}