Glucose Tolerance in Healthy Overweight Adults

Overweight Clinical Trial

Official title:

Glucose Tolerance in Healthy Overweight Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00974831
• Other study ID #: BK51
• Status: Completed
• Phase: Phase 2
• First received: September 9, 2009
• Last updated: November 24, 2010
• Start date: July 2009
• Est. completion date: October 2009

Study information

• Verified date: November 2009
• Source: Abbott Nutrition
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Overweight

Intervention

Other:
• Amino Acid Drink Mixture
22 oz consumed in 7 oz, 8oz, 7 oz increments 5 minutes apart over 15 mins
• Glucose drink
22 oz consumed in 7 oz, 8oz, 7 oz increments 5 minutes apart over 15 mins

Locations

Country	Name	City	State
United States	University of Texas	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Nutrition

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary variable is the positive area under the curve from 0 to 180 minutes for plasma glucose.		0-180 minutes	No
Secondary	Plasma glucose, insulin, C-peptide, free fatty acids, and glucagon concentration data over time		0-180 minutes	No