Ignite Creation Date:
2025-12-24 @ 7:16 PM
Ignite Modification Date:
2026-01-04 @ 6:48 AM
Study NCT ID:
NCT02388503
Status:
COMPLETED
Last Update Posted:
2015-05-01
First Post:
2015-02-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of a Natural Extract on the Post-prandial Blood Glucose Response After Bread Consumption: a Dose-response of Efficacy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D005638', 'term': 'Fruit'}], 'ancestors': [{'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-30', 'studyFirstSubmitDate': '2015-02-10', 'studyFirstSubmitQcDate': '2015-03-13', 'lastUpdatePostDateStruct': {'date': '2015-05-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-03-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Positive incremental post-prandial blood glucose area under the curve', 'timeFrame': '120 minutes'}], 'secondaryOutcomes': [{'measure': 'Post-prandial insulin response', 'timeFrame': '120 minutes'}, {'measure': 'Post-prandial insulin response', 'timeFrame': '180 minutes'}, {'measure': 'AUC of fruit extract calculated by a non-compartmental model', 'timeFrame': '180 minutes'}, {'measure': 'AUC of fruit extract calculated by a population model', 'timeFrame': '180 minutes'}, {'measure': 'Positive incremental post-prandial blood glucose area under the curve', 'timeFrame': '180 minutes'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Blood glucose'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'This study is designed to identify the minimal effective tested dose of fruit extract consumed with a bread which provides a reduction in venous post-prandial blood glucose compared to a reference bread.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Body mass index (BMI) ≥ 18.0 and ≤ 30.0 kg/m2.\n* Apparently healthy males and females: no medical conditions which might affect the study measurements including diabetes type 1 and type 2, gastrointestinal dysfunction, gastrointestinal surgery and inflammatory diseases.\n* Fasting blood glucose value of subjects ≥ 3.4 and ≤ 6.1 mmol/litre (i.e. 62-110 mg/dl) at screening.\n\nExclusion criteria:\n\n* Use of antibiotics within 3 months before day 1; use of any other medication except paracetamol, within 14 days before day 1.\n* Blood donation in the past 3 months and/or during the study.\n* Reported intense sporting activities \\> 10 h/week.\n* Consumption of \\> 14 units (female subjects) and \\> 21 units (male subjects) alcoholic drinks in a typical week.\n* Reported dietary habits: medically prescribed diet, slimming diet, not used to eat 3 meals a day, vegetarian.\n* If female, is pregnant (or has been pregnant during the last \\< 3 months) or will be planning pregnancy during the study period.\n* If female, is lactating or has been lactating in the 6 weeks before screening and/or during the study period.\n* Dislike, known allergy or intolerance to test products or other food products provided during the study.'}, 'identificationModule': {'nctId': 'NCT02388503', 'briefTitle': 'The Effect of a Natural Extract on the Post-prandial Blood Glucose Response After Bread Consumption: a Dose-response of Efficacy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Unilever R&D'}, 'officialTitle': 'The Effect of a Natural Extract on the Post-prandial Blood Glucose Response After Bread Consumption: a Dose-response of Efficacy', 'orgStudyIdInfo': {'id': 'FDS-NAA-1946'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Reference', 'description': 'No added fruit extract', 'interventionNames': ['Dietary Supplement: no added fruit extract']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Active 1', 'description': 'lowest dose of fruit extract', 'interventionNames': ['Dietary Supplement: fruit extract']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Active 2', 'description': 'low dose of fruit extract', 'interventionNames': ['Dietary Supplement: fruit extract']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Active 3', 'description': 'medium dose of fruit extract', 'interventionNames': ['Dietary Supplement: fruit extract']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Active 4', 'description': 'high dose of fruit extract', 'interventionNames': ['Dietary Supplement: fruit extract']}], 'interventions': [{'name': 'no added fruit extract', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Reference']}, {'name': 'fruit extract', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Active 1']}, {'name': 'fruit extract', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Active 2']}, {'name': 'fruit extract', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Active 3']}, {'name': 'fruit extract', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Active 4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10117', 'city': 'Berlin', 'state': 'Charitéplatz 1', 'country': 'Germany', 'facility': 'Charité research organisation', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Unilever R&D', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}