Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2025-12-25 @ 9:34 PM
Study NCT ID:
NCT03714451
Status:
COMPLETED
Last Update Posted:
2023-02-14
First Post:
2018-10-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Investigating the Effect of Onyx Sorghum on Blood Glucose in Individuals With Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'double blinded'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'double blinded randomized'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2022-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-10', 'studyFirstSubmitDate': '2018-10-18', 'studyFirstSubmitQcDate': '2018-10-18', 'lastUpdatePostDateStruct': {'date': '2023-02-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Eating behavior', 'timeFrame': 'day 1', 'description': 'measure of food provided and returned'}, {'measure': 'Eating behavior', 'timeFrame': 'day 14', 'description': 'measure of food provided and returned'}, {'measure': 'Eating behavior', 'timeFrame': 'day 28', 'description': 'measure of food provided and returned'}], 'primaryOutcomes': [{'measure': 'Change in glycemic variability', 'timeFrame': 'day 1', 'description': 'The continuous glucose monitoring (CGM) consists of a sensor that measures glucose levels from the interstitial tissue. Changes in glucose levels from baseline.'}, {'measure': 'Change in glycemic variability', 'timeFrame': '14 days', 'description': 'The continuous glucose monitoring (CGM) consists of a sensor that measures glucose levels from the interstitial tissue. Changes in glucose levels from baseline.'}, {'measure': 'Change in glycemic variability', 'timeFrame': 'day 28', 'description': 'The continuous glucose monitoring (CGM) consists of a sensor that measures glucose levels from the interstitial tissue. Changes in glucose levels from baseline.'}], 'secondaryOutcomes': [{'measure': 'Changes in weight', 'timeFrame': 'day 1', 'description': 'change in weight from baseline'}, {'measure': 'Changes in weight', 'timeFrame': 'day 14', 'description': 'change in weight from baseline'}, {'measure': 'Changes in weight', 'timeFrame': 'day 28', 'description': 'change in weight from baseline'}, {'measure': 'Changes in BMI', 'timeFrame': 'upon screening', 'description': 'change in BMI from baseline'}, {'measure': 'Changes in BMI', 'timeFrame': 'day 1', 'description': 'change in BMI from baseline'}, {'measure': 'Changes in BMI', 'timeFrame': 'day 14', 'description': 'change in BMI from baseline'}, {'measure': 'Changes in BMI', 'timeFrame': 'day 28', 'description': 'change in BMI from baseline'}, {'measure': 'Change in glucose levels', 'timeFrame': 'upon enrollment', 'description': 'change in blood glucose levels'}, {'measure': 'Change in glucose levels', 'timeFrame': 'day 1', 'description': 'change in blood glucose levels'}, {'measure': 'Change in glucose levels', 'timeFrame': 'day 14', 'description': 'change in blood glucose levels'}, {'measure': 'Change in glucose levels', 'timeFrame': 'day 28', 'description': 'change in blood glucose levels'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Type 2']}, 'descriptionModule': {'briefSummary': 'To evaluate the effect of onyx sorghum on blood glucose levels in patients with type 2 diabetes (T2DM).', 'detailedDescription': 'The plan is to study 24 participants with T2DM, who are otherwise healthy. The study will be double-blinded and randomized. Participants will first attend a screening visit (Visit #1) to determine eligibility. Then, eligible participants will be asked to wear a FreeStyle Libre Pro continuous glucose monitor (CGM) for up to 14 days (Visit #2). After this 14-day CGM session, participants will be randomly assigned (1:1) to one of two groups that will receive: 1) food products containing onyx sorghum (Onyx Group) or 2) food products with wheat flour (Control Group). The diet intervention will last a total of 28 days. Participants will have weekly visits to pick up food and bi-weekly blood draws (no more than 20mL at each visit). They will also be asked to wear the CGM throughout the diet intervention and will record their food intake in a daily food diary to confirm that the diet intervention is being followed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ages 30-65 years\n* A1c \\< 8.5%\n* BMI \\> 18.5\n\nExclusion Criteria:\n\n* known malignancy, anemia, kidney disease, and/or liver disease\n* untreated thyroid disease\n* uncontrolled hypertension\n* initiation of any anti-diabetes medications within the last 3 months\n* greater than 5% change in weight in the last 3 months\n* current or recent steroid use in the last 3 months\n* for women: pregnancy or breastfeeding'}, 'identificationModule': {'nctId': 'NCT03714451', 'briefTitle': 'Investigating the Effect of Onyx Sorghum on Blood Glucose in Individuals With Type 2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'Investigating the Effect of Onyx Sorghum on Blood Glucose in Individuals With Type 2 Diabetes', 'orgStudyIdInfo': {'id': '2000023930'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Onyx Group', 'description': 'Patients with T2DM will receive food products containing onyx sorghum (Onyx Group).', 'interventionNames': ['Dietary Supplement: onyx sorghum']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Wheat Flour Group', 'description': 'Patients with T2DM will receive food products with wheat flour.', 'interventionNames': ['Dietary Supplement: whole wheat flour']}], 'interventions': [{'name': 'onyx sorghum', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The diet intervention will last a total of 28 days. Per the American Heart Association (AHA) and American Diabetes Association (ADA) recommendations, the daily diet plan will consist of 50-55% carbohydrate, 15-20% protein, and 25-30% fat. In the Onyx Group, 25% of carbohydrate will come from the onyx sorghum, and at least three foods per day (including cereals, bread, muffins, pasta, and smoothie boosters) will contain this.', 'armGroupLabels': ['Onyx Group']}, {'name': 'whole wheat flour', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Per the American Heart Association (AHA) and American Diabetes Association (ADA) recommendations, the daily diet plan will consist of 50-55% carbohydrate, 15-20% protein, and 25-30% fat.', 'armGroupLabels': ['Wheat Flour Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale New Haven Hospital', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale University School of Medicine', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '06519', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale Center for Clinical Investigation', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], 'overallOfficials': [{'name': 'Renata Belfort de Aguiar, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yale School of Medicine Department of Endocrinology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Silver Palate Kitchens Inc.', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}