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Glucose Tolerance in Healthy Overweight Adults

This study has been completed.
Sponsor:
Information provided by:
Abbott Nutrition
ClinicalTrials.gov Identifier:
NCT00974831
First received: September 9, 2009
Last updated: November 24, 2010
Last verified: November 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Overweight
 Other: Amino Acid Drink Mixture
Other: Glucose drink
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Glucose Tolerance in Healthy Overweight Adults

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Abbott Nutrition:

Primary Outcome Measures:
  • The primary variable is the positive area under the curve from 0 to 180 minutes for plasma glucose. [ Time Frame: 0-180 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Plasma glucose, insulin, C-peptide, free fatty acids, and glucagon concentration data over time [ Time Frame: 0-180 minutes ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: July 2009
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AA Drink
Amino Acid Drink Mixture
 Other: Amino Acid Drink Mixture
22 oz consumed in 7 oz, 8oz, 7 oz increments 5 minutes apart over 15 mins
Placebo Comparator: Glucose drink Other: Glucose drink
22 oz consumed in 7 oz, 8oz, 7 oz increments 5 minutes apart over 15 mins

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00974831

Locations
United States, Texas
University of Texas
Austin, Texas, United States, 78712
Sponsors and Collaborators
Abbott Nutrition
Investigators
Study Chair: Jeffrey Nelson, PhD Abbott Nutrition
  More Information

No publications provided

Responsible Party: Bobbie L Swearengin, RN, Abbott Nutrition
ClinicalTrials.gov Identifier: NCT00974831     History of Changes
Other Study ID Numbers: BK51
Study First Received: September 9, 2009
Last Updated: November 24, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 22, 2013