Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2025-12-26 @ 3:29 AM
Study NCT ID:
NCT04313920
Status:
COMPLETED
Last Update Posted:
2020-10-06
First Post:
2020-03-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of a Carbohydrate Drink in Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019587', 'term': 'Dietary Supplements'}], '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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 97}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-04-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2020-08-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-02', 'studyFirstSubmitDate': '2020-03-11', 'studyFirstSubmitQcDate': '2020-03-17', 'lastUpdatePostDateStruct': {'date': '2020-10-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma Glucose Concentration', 'timeFrame': 'Baseline 0 to 240 Minutes', 'description': 'Area under the curve'}], 'secondaryOutcomes': [{'measure': 'Serum Insulin Concentration', 'timeFrame': 'Baseline 0 to 240 Minutes', 'description': 'Area under the curve'}, {'measure': 'Nutritional Product Assessment', 'timeFrame': 'Immediately following product consumption', 'description': 'Subject completed questionnaire with 2 product liking questions using 7-9 point Likert scale'}, {'measure': 'Subjective Appetitive Ratings', 'timeFrame': 'Baseline 0 to 240 Minutes', 'description': 'Subject completed 4 visual analog scale statements scaled from Not at All to Extremely'}, {'measure': 'Gastric Emptying', 'timeFrame': 'Baseline 0 to 180 Minutes', 'description': 'Rate of gastric emptying'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Glycemic Response']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to determine the postprandial glycemic response and rates of gastric emptying in healthy subjects and those with pre-diabetes and type 2 diabetes following oral ingestion of carbohydrate.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject has voluntarily signed and dated an informed consent form and provided Health Insurance Portability and Accountability Act (HIPAA) authorization\n* Subject is healthy or has pre-diabetes or type 2 diabetes\n* Subject is a male or a non-pregnant, non-lactating female, at least 6 weeks postpartum\n* Subject's BMI is \\> 18.5 kg/m2 and ≤ 40.0 kg/m2\n* If subject is on a chronic medication, the dosage has been constant\n* Subject states willingness to follow protocol\n\nExclusion Criteria:\n\n* Subject uses exogenous insulin or Glucagon-like peptide-1 (GLP-1) receptor agonists for glucose control\n* Subject has type 1 diabetes\n* Subject has a history of diabetic ketoacidosis\n* Subject has current infection; has had in-patient surgery, or corticosteroid treatment or antibiotics\n* Subject has an active malignancy\n* Subject has had a significant cardiovascular event ≤ six months or history of congestive heart failure\n* Subject has end-stage organ failure or is status post organ transplant.\n* Subject has a history of renal disease\n* Subject has current hepatic disease\n* Subject has a history of severe gastroparesis\n* Subject has a chronic, contagious, infectious disease\n* Subject has taken/is currently taking any herbals, dietary supplements, or medications that could profoundly affect blood glucose\n* Subject has clotting or bleeding disorders\n* Subject is known to be allergic or intolerant to any ingredient found in the study products\n* Subject is a participant in another study that has not been approved as a concomitant study"}, 'identificationModule': {'nctId': 'NCT04313920', 'briefTitle': 'Study of a Carbohydrate Drink in Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Nutrition'}, 'officialTitle': 'Postprandial Gastric Emptying and Glycemic Response to a Pre-Operative Carbohydrate Drink in Adults With Pre-diabetes and Type II Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'BL48'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nutritional Supplement', 'description': 'Ready to drink liquid', 'interventionNames': ['Other: Nutritional Supplement']}], 'interventions': [{'name': 'Nutritional Supplement', 'type': 'OTHER', 'description': '50 g Carbohydrate', 'armGroupLabels': ['Nutritional Supplement']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33458', 'city': 'Jupiter', 'state': 'Florida', 'country': 'United States', 'facility': 'Health Awareness, Inc.', 'geoPoint': {'lat': 26.93422, 'lon': -80.09421}}, {'zip': '60101', 'city': 'Addison', 'state': 'Illinois', 'country': 'United States', 'facility': 'Biofortis', 'geoPoint': {'lat': 41.9317, 'lon': -87.98896}}, {'zip': '60640', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Great Lakes Clinical Trials', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Bridget Cassady, PhD, RDN, LD', 'role': 'STUDY_CHAIR', 'affiliation': 'Abbott Nutrition'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Nutrition', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}