Glucose Tolerance in Healthy Overweight Adults
Overview
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.
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Primary Purpose: Treatment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Study Primary Completion Date: October 2009
Interventions
- Other: Amino Acid Drink Mixture
- 22 oz consumed in 7 oz, 8oz, 7 oz increments 5 minutes apart over 15 mins
- Other: Glucose drink
- 22 oz consumed in 7 oz, 8oz, 7 oz increments 5 minutes apart over 15 mins
Arms, Groups and Cohorts
- Experimental: AA Drink
- Amino Acid Drink Mixture
- Placebo Comparator: Glucose drink
Clinical Trial Outcome Measures
Primary Measures
- The primary variable is the positive area under the curve from 0 to 180 minutes for plasma glucose.
- Time Frame: 0-180 minutes
Secondary Measures
- Plasma glucose, insulin, C-peptide, free fatty acids, and glucagon concentration data over time
- Time Frame: 0-180 minutes
Participating in This Clinical Trial
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.
Gender Eligibility: All
Minimum Age: 20 Years
Maximum Age: 45 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
Investigator Details
- Lead Sponsor
- Abbott Nutrition
- Provider of Information About this Clinical Study
- Bobbie L Swearengin, RN, Abbott Nutrition
- Overall Official(s)
- Jeffrey Nelson, PhD, Study Chair, Abbott Nutrition
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