Ignite Creation Date:
2025-12-25 @ 12:08 AM
Ignite Modification Date:
2026-01-25 @ 7:37 AM
Study NCT ID:
NCT02940158
Status:
COMPLETED
Last Update Posted:
2018-05-08
First Post:
2016-09-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Various Serving Sizes of Lentils on Blood Glucose and Insulin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], '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'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2018-01-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-02', 'studyFirstSubmitDate': '2016-09-25', 'studyFirstSubmitQcDate': '2016-10-18', 'lastUpdatePostDateStruct': {'date': '2018-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-01-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postprandial Blood Glucose', 'timeFrame': '2 hours Postprandial'}, {'measure': 'Postprandial Blood Insulin', 'timeFrame': '2 hours postprandial'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['lentils', 'diabetes', 'glycemia', 'insulin', 'glucose'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the effects of consuming either 1/2 or 1/4 cup servings of lentils on post-prandial blood glucose and insulin as compared to 4 types of starchy foods (corn, macaroni, white potato, white rice).', 'detailedDescription': 'Eligible participants will undergo a total of 6 study visits. During each visit, a fasted blood sample will be taken by fingerprick, and approximately 500 µL of blood will be dripped into a collection tube. The participant will then consume a meal of either: two types of lentils, corn, macaroni, white rice, or white potato. All study days will be randomized. Each meal will be served in either 1/4 or 1/2 cup servings depending on the study block. Six more blood samples will be taken by fingerprick at 15, 30, 45, 60, 90 and 120 minutes after the beginning of the meal.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Healthy men and women\n* Age 18-40 years\n* Body mass index (BMI) 20-30 kg/m2\n\nExclusion Criteria:\n\n* Tobacco use\n* Pregnant or breastfeeding\n* Fasting blood glucose ≥ 7.0 mmol/L\n* Two hour blood glucose ≥ 11.1 mmol/L after consuming 75g glucose drink (Oral Glucose Tolerance Test beverage)\n* Any major medical condition including a history of AIDS or hepatitis\n* Medical or surgical event requiring hospitalization within 3 months of randomization\n* Any medications except a stable dose (3 months) of oral contraceptives, blood pressure or statin medications\n* Blood pressure \\>140/90 mm Hg\n* Natural health products (NHPs) used for glycemic control\n* Probiotic supplements\n* Dietary fibre supplements\n* Consumption of \\>4 servings of pulses per week\n* Food allergy or non-food life threatening allergy\n* Shift workers\n* Alcohol consumption \\>14 drinks/week or \\>4 drinks/sitting\n* Recent or intended significant weight loss or gain (\\>4 kg in previous 3 months)\n* Elite athletes'}, 'identificationModule': {'nctId': 'NCT02940158', 'briefTitle': 'Various Serving Sizes of Lentils on Blood Glucose and Insulin', 'organization': {'class': 'OTHER', 'fullName': 'University of Guelph'}, 'officialTitle': 'The Effect of Various Serving Sizes of Lentils and Other Starchy Meals on Post Prandial Blood Glucose Response and Insulin', 'orgStudyIdInfo': {'id': '16AU001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': '1/2 cup', 'description': '1/2 cup serving size arm', 'interventionNames': ['Other: 1/2 cup- small red lentil', 'Other: 1/2 cup- small green lentil', 'Other: 1/2 cup- corn', 'Other: 1/2 cup- macaroni', 'Other: 1/2 cup- white potato', 'Other: 1/2 cup- white rice']}, {'type': 'OTHER', 'label': '1/4 cup', 'description': '1/4 cup serving size arm', 'interventionNames': ['Other: 1/4 cup- Small red lentil', 'Other: 1/4 cup- Small green lentil', 'Other: 1/4 cup- corn', 'Other: 1/4 cup- macaroni', 'Other: 1/4 cup- white potato', 'Other: 1/4 cup- white rice']}], 'interventions': [{'name': '1/4 cup- Small red lentil', 'type': 'OTHER', 'armGroupLabels': ['1/4 cup']}, {'name': '1/4 cup- Small green lentil', 'type': 'OTHER', 'armGroupLabels': ['1/4 cup']}, {'name': '1/4 cup- corn', 'type': 'OTHER', 'armGroupLabels': ['1/4 cup']}, {'name': '1/4 cup- macaroni', 'type': 'OTHER', 'armGroupLabels': ['1/4 cup']}, {'name': '1/4 cup- white potato', 'type': 'OTHER', 'armGroupLabels': ['1/4 cup']}, {'name': '1/4 cup- white rice', 'type': 'OTHER', 'armGroupLabels': ['1/4 cup']}, {'name': '1/2 cup- small red lentil', 'type': 'OTHER', 'armGroupLabels': ['1/2 cup']}, {'name': '1/2 cup- small green lentil', 'type': 'OTHER', 'armGroupLabels': ['1/2 cup']}, {'name': '1/2 cup- corn', 'type': 'OTHER', 'armGroupLabels': ['1/2 cup']}, {'name': '1/2 cup- macaroni', 'type': 'OTHER', 'armGroupLabels': ['1/2 cup']}, {'name': '1/2 cup- white potato', 'type': 'OTHER', 'armGroupLabels': ['1/2 cup']}, {'name': '1/2 cup- white rice', 'type': 'OTHER', 'armGroupLabels': ['1/2 cup']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N1G 2W1', 'city': 'Guelph', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Human Nutraceutical Research Unit', 'geoPoint': {'lat': 43.54594, 'lon': -80.25599}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Guelph', 'class': 'OTHER'}, 'collaborators': [{'name': 'Agriculture and Agri-Food Canada', 'class': 'OTHER_GOV'}, {'name': 'Saskatchewan Pulse Growers', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Alison Duncan', 'investigatorAffiliation': 'University of Guelph'}}}}