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OpenTrials
Completed

NCT Number: NCT00974831

Glucose Tolerance in Healthy Overweight Adults

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.

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Key information

Age range

20 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Texas

Austin, Texas, 78712, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Amino Acid Drink Mixture

Other

22 oz consumed in 7 oz, 8oz, 7 oz increments 5 minutes apart over 15 mins

Glucose drink

Other

22 oz consumed in 7 oz, 8oz, 7 oz increments 5 minutes apart over 15 mins

Primary outcomes

  1. The primary variable is the positive area under the curve from 0 to 180 minutes for plasma glucose.

    Time frame: 0-180 minutes

Secondary outcomes

  1. Plasma glucose, insulin, C-peptide, free fatty acids, and glucagon concentration data over time

    Time frame: 0-180 minutes

Sponsors and collaborators

Lead sponsor

Abbott Nutrition

Industry

Registry information

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Sep 10, 2009
Registry last updated
Nov 25, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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