Overweight
Conditions
Brief summary
The primary objective is to compare the postprandial glycemic response of healthy overweight adults after consuming an amino acid drink mix versus a control drink.
Interventions
OTHERAmino Acid Drink Mixture
22 oz consumed in 7 oz, 8oz, 7 oz increments 5 minutes apart over 15 mins
OTHERGlucose drink
22 oz consumed in 7 oz, 8oz, 7 oz increments 5 minutes apart over 15 mins
Sponsors
Abbott Nutrition
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Fasting blood glucose level of ≥ 70mg/dL and ≤ 125 mg/dL. 2. Subject states that he/she does not have type 1 or 2 diabetes. 3. Subject is overweight as defined as waist circumference ≥ 101 cm (40 inches) male; ≥ 88 cm (35 inches) female. 4. Subject's BMI is ≥ 25 kg/m2. 5. Subject's blood pressure is \< 140 mm Hg systolic and \< 90 mm Hg diastolic. 6. Subject is between 20 and 45 years of age, inclusive. 7. Subject is a male or a non-pregnant, non-lactating female, at least 6 weeks postpartum prior to screening visit. 8. If female is of childbearing potential, is practicing birth control 9. If subject is on a chronic medication such as a thyroid medication or hormone therapy, has been on constant dosage for at least two months prior to screening visit.
Exclusion criteria
1. Subject is eating a low carbohydrate diet such as Atkins, Zone, or South Beach diet plan. 2. Subject states that he/she has current infection, has had inpatient surgery, or corticosteroid treatment in the last 3 months or antibiotics in the last 3 weeks prior to screening visit. 3. Subject states that he/she has an active malignancy. 4. Subject states that he/she has had a significant cardiovascular event ≤ six months prior to screening visit; or stated history of congestive heart failure. 5. Subject states that he/she has end-stage organ failure or is status post organ transplant. 6. Subject states that he/she has a history of renal disease. 7. Subject states that he/she has current hepatic disease. 8. Subject states that he/she has a chronic, contagious, infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV. 9. Subject has taken/is currently taking any herbals, dietary supplements, or medications during the past four weeks prior to screening visit that could profoundly affect blood glucose. 10. Subject has taken/is currently taking any herbals, dietary supplements, or medications during the past four weeks prior to screening visit to control hypertension or cholesterol. 11. Subject states that he/she has clotting or bleeding disorders.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary variable is the positive area under the curve from 0 to 180 minutes for plasma glucose. | 0-180 minutes |
Secondary
| Measure | Time frame |
|---|---|
| Plasma glucose, insulin, C-peptide, free fatty acids, and glucagon concentration data over time | 0-180 minutes |
Countries
United States
Outcome results
None listed