Study of a Carbohydrate Drink in Adults
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Nutritional Supplement Ready to drink liquid |
Other: Nutritional Supplement
50 g Carbohydrate
|
Outcome Measures
Primary Outcome Measures
- Plasma Glucose Concentration [Baseline 0 to 240 Minutes]
Area under the curve
Secondary Outcome Measures
- Serum Insulin Concentration [Baseline 0 to 240 Minutes]
Area under the curve
- Nutritional Product Assessment [Immediately following product consumption]
Subject completed questionnaire with 2 product liking questions using 7-9 point Likert scale
- Subjective Appetitive Ratings [Baseline 0 to 240 Minutes]
Subject completed 4 visual analog scale statements scaled from Not at All to Extremely
- Gastric Emptying [Baseline 0 to 180 Minutes]
Rate of gastric emptying
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Health Awareness, Inc. | Jupiter | Florida | United States | 33458 |
| 2 | Biofortis | Addison | Illinois | United States | 60101 |
| 3 | Great Lakes Clinical Trials | Chicago | Illinois | United States | 60640 |
Sponsors and Collaborators
- Abbott Nutrition
Investigators
- Study Chair: Bridget Cassady, PhD, RDN, LD, Abbott Nutrition
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BL48