Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2026-01-29 @ 2:47 AM
Study NCT ID:
NCT03192605
Status:
COMPLETED
Last Update Posted:
2017-06-20
First Post:
2017-06-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Wild Blueberry Consumption on Glucose Regulation in Healthy Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000721609', 'term': 'blueberry extract'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2017-06-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-19', 'studyFirstSubmitDate': '2017-06-16', 'studyFirstSubmitQcDate': '2017-06-19', 'lastUpdatePostDateStruct': {'date': '2017-06-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glucose (mmol/L)', 'timeFrame': 'Change from baseline 0 hours and 2 hours', 'description': 'Plasma glucose'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes']}, 'descriptionModule': {'briefSummary': 'The objective of the study is to determine how wild blueberry consumption affects glucose regulation, gastrointestinal hormones and satiety in healthy adults.', 'detailedDescription': 'Healthy men and women (ages 21 - 65 years) were recruited to take part in a randomized, placebo controlled crossover design study. Subjects were screened to determine their health status (e.g. height, weight, body mass index, blood pressure and medical history). Subjects were randomly assigned to a sequence of two treatments with two study periods. The treatments are frozen wild blueberries and a placebo developed to match calories and fiber of the frozen wild blueberries. The subjects were asked to avoid high polyphenol foods in their typical diet for 7 days and consume one of the two treatments as a dietary intervention. After the seventh day subjects consumed a test meal along with either the wild blueberry or placebo. Blood was collected to determine glucose and satiety hormone levels.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female\n\nExclusion Criteria:\n\n* BMI \\< 20 and \\> 30 kg/m²\n* Pregnant women or women who plan on becoming pregnant during the study\n* Postpartum women\n* Lactating women\n* Diabetes Mellitus\n* Kidney disease\n* Liver disease\n* GI Disease\n* Certain cancers\n* Smokers\n* Blueberry allergies'}, 'identificationModule': {'nctId': 'NCT03192605', 'briefTitle': 'The Effect of Wild Blueberry Consumption on Glucose Regulation in Healthy Adults', 'organization': {'class': 'OTHER', 'fullName': 'University of Prince Edward Island'}, 'officialTitle': 'The Effect of Wild Blueberry Consumption on Diabetes: Evaluation of Glucose Regulation, Gastrointestinal Hormones and Satiety in Healthy Adults', 'orgStudyIdInfo': {'id': 'UPEI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Blueberry', 'description': '150 grams wild blueberries', 'interventionNames': ['Other: Blueberry']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo control', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Blueberry', 'type': 'OTHER', 'description': 'Blueberry - 150 grams wild blueberries (whole fruit)', 'armGroupLabels': ['Blueberry']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo - matched for calories and fiber', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'C1A 4P3', 'city': 'Charlottetown', 'state': 'Prince Edward Island', 'country': 'Canada', 'facility': 'University of Prince Edward Island, Health Sciences', 'geoPoint': {'lat': 46.23459, 'lon': -63.1256}}], 'overallOfficials': [{'name': 'Katherine Gottschall-Pass, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Prince Edward Island'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Data will be shared as requested by other researchers. It may be made available by June 2018.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Prince Edward Island', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Chair of Nutrisciences and Health', 'investigatorFullName': 'Kim Stote', 'investigatorAffiliation': 'University of Prince Edward Island'}}}}