Glycemic Response
Conditions
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.
Interventions
OTHERNutritional Supplement
50 g Carbohydrate
Sponsors
Abbott Nutrition
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma Glucose Concentration | Baseline 0 to 240 Minutes | Area under the curve |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed