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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014