Glucose Tolerance in Healthy Overweight Adults

Study Overview
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Brief Summary
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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.

Official Title
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Glucose Tolerance in Healthy Overweight Adults

Conditions
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Overweight

Intervention / Treatment
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* Other: Amino Acid Drink Mixture
* Other: Glucose drink


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Fasting blood glucose level of ≥ 70mg/dL and ≤ 125 mg/dL. Subject states that he/she does not have type 1 or 2 diabetes. Subject is overweight as defined as waist circumference ≥ 101 cm (40 inches) male; ≥ 88 cm (35 inches) female. Subject's BMI is ≥ 25 kg/m2. Subject's blood pressure is < 140 mm Hg systolic and < 90 mm Hg diastolic. Subject is between 20 and 45 years of age, inclusive. Subject is a male or a non-pregnant, non-lactating female, at least 6 weeks postpartum prior to screening visit. If female is of childbearing potential, is practicing birth control 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: Subject is eating a low carbohydrate diet such as Atkins, Zone, or South Beach diet plan. 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. Subject states that he/she has an active malignancy. Subject states that he/she has had a significant cardiovascular event ≤ six months prior to screening visit; or stated history of congestive heart failure. Subject states that he/she has end-stage organ failure or is status post organ transplant. Subject states that he/she has a history of renal disease. Subject states that he/she has current hepatic disease. Subject states that he/she has a chronic, contagious, infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV. 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. 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. Subject states that he/she has clotting or bleeding disorders.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AA Drink<br>Amino Acid Drink Mixture | Other: Amino Acid Drink Mixture<br>* 22 oz consumed in 7 oz, 8oz, 7 oz increments 5 minutes apart over 15 mins<br>|
| Placebo Comparator: Glucose drink<br> | Other: Glucose drink<br>* 22 oz consumed in 7 oz, 8oz, 7 oz increments 5 minutes apart over 15 mins<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary variable is the positive area under the curve from 0 to 180 minutes for plasma glucose. |  | 0-180 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma glucose, insulin, C-peptide, free fatty acids, and glucagon concentration data over time |  | 0-180 minutes |