Glucose Tolerance in Healthy Overweight Adults

Phase 2

Completed

• Conditions: Overweight
• Interventions: Other: Amino Acid Drink Mixture; Other: Glucose drink

• Registration Number: NCT00974831
• Lead Sponsor: Abbott Nutrition

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-09-09
• Study First Submitted QC: 2009-09-09
• Study First Posted: 2009-09-10
• Primary Completion: 2009-10
• Study Completion: 2009-10
• Status Verified: 2009-11
• Last Update Submitted: 2010-11-24
• Last Update Posted: 2010-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
AA Drink	Amino Acid Drink Mixture	Amino Acid Drink Mixture
Glucose drink	Glucose drink	-

Primary Outcome Measures

Name	Time	Method
The primary variable is the positive area under the curve from 0 to 180 minutes for plasma glucose.	0-180 minutes

Secondary Outcome Measures

Name	Time	Method
Plasma glucose, insulin, C-peptide, free fatty acids, and glucagon concentration data over time	0-180 minutes

Trial Locations

Locations (1)

University of Texas; 🇺🇸 Austin, Texas, United States