Study of a Carbohydrate Drink in Adults
Not Applicable
Completed
- Conditions
- Glycemic Response
- Interventions
- Other: Nutritional Supplement
- Registration Number
- NCT04313920
- Lead Sponsor
- Abbott Nutrition
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 97
Inclusion Criteria
- Subject has voluntarily signed and dated an informed consent form and provided Health Insurance Portability and Accountability Act (HIPAA) authorization
- Subject is healthy or has pre-diabetes or type 2 diabetes
- Subject is a male or a non-pregnant, non-lactating female, at least 6 weeks postpartum
- Subject's BMI is > 18.5 kg/m2 and ≤ 40.0 kg/m2
- If subject is on a chronic medication, the dosage has been constant
- Subject states willingness to follow protocol
Exclusion Criteria
- Subject uses exogenous insulin or Glucagon-like peptide-1 (GLP-1) receptor agonists for glucose control
- Subject has type 1 diabetes
- Subject has a history of diabetic ketoacidosis
- Subject has current infection; has had in-patient surgery, or corticosteroid treatment or antibiotics
- Subject has an active malignancy
- Subject has had a significant cardiovascular event ≤ six months or history of congestive heart failure
- Subject has end-stage organ failure or is status post organ transplant.
- Subject has a history of renal disease
- Subject has current hepatic disease
- Subject has a history of severe gastroparesis
- Subject has a chronic, contagious, infectious disease
- Subject has taken/is currently taking any herbals, dietary supplements, or medications that could profoundly affect blood glucose
- Subject has clotting or bleeding disorders
- Subject is known to be allergic or intolerant to any ingredient found in the study products
- Subject is a participant in another study that has not been approved as a concomitant study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Nutritional Supplement Nutritional Supplement Ready to drink liquid
- Primary Outcome Measures
Name Time Method Plasma Glucose Concentration Baseline 0 to 240 Minutes Area under the curve
- Secondary Outcome Measures
Name Time Method Gastric Emptying Baseline 0 to 180 Minutes Rate of gastric emptying
Nutritional Product Assessment Immediately following product consumption Subject completed questionnaire with 2 product liking questions using 7-9 point Likert scale
Serum Insulin Concentration Baseline 0 to 240 Minutes Area under the curve
Subjective Appetitive Ratings Baseline 0 to 240 Minutes Subject completed 4 visual analog scale statements scaled from Not at All to Extremely
Trial Locations
- Locations (3)
Health Awareness, Inc.
🇺🇸Jupiter, Florida, United States
Biofortis
🇺🇸Addison, Illinois, United States
Great Lakes Clinical Trials
🇺🇸Chicago, Illinois, United States