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Glucose Tolerance in Healthy Overweight Adults

Primary Purpose

Overweight

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Amino Acid Drink Mixture

Glucose drink

About this trial

This is an interventional treatment trial for Overweight

Eligibility Criteria

20 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

University of Texas

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

AA Drink

Glucose drink

Arm Description

Amino Acid Drink Mixture

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00974831

First Posted

September 9, 2009

Last Updated

November 24, 2010

Sponsor

Abbott Nutrition

1. Study Identification

Unique Protocol Identification Number

NCT00974831

Brief Title

Glucose Tolerance in Healthy Overweight Adults

Official Title

Glucose Tolerance in Healthy Overweight Adults

Study Type

Interventional

2. Study Status

Record Verification Date

November 2009

Overall Recruitment Status

Completed

Study Start Date

July 2009 (undefined)

Primary Completion Date

October 2009 (Actual)

Study Completion Date

October 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Abbott Nutrition

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Overweight

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

AA Drink

Arm Type

Experimental

Arm Description

Amino Acid Drink Mixture

Arm Title

Glucose drink

Arm Type

Placebo Comparator

Intervention Type

Other

Intervention Name(s)

Amino Acid Drink Mixture

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Glucose drink

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

0-180 minutes

Secondary Outcome Measure Information:

Title

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

Time Frame

0-180 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jeffrey Nelson, PhD

Organizational Affiliation

Abbott Nutrition

Official's Role

Study Chair

Facility Information:

Facility Name

University of Texas

City

Austin

State/Province

Texas

ZIP/Postal Code

78712

Country

United States

12. IPD Sharing Statement

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Glucose Tolerance in Healthy Overweight Adults

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