NCT00974831

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jul 2009

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 10, 2009

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

November 25, 2010

Status Verified

November 1, 2009

Enrollment Period

3 months

First QC Date

September 9, 2009

Last Update Submit

November 24, 2010

Conditions

Overweight

Outcome Measures

Primary Outcomes (1)

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

    0-180 minutes

Secondary Outcomes (1)

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

    0-180 minutes

Study Arms (2)

AA Drink

EXPERIMENTAL

Amino Acid Drink Mixture

Other: Amino Acid Drink Mixture

Glucose drink

PLACEBO COMPARATOR
Other: Glucose drink

Interventions

Amino Acid Drink MixtureOTHER

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

AA Drink
Glucose drinkOTHER

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

Glucose drink

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas

Austin, Texas, 78712, United States

Location

MeSH Terms

Conditions

Overweight

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jeffrey Nelson, PhD

    Abbott Nutrition

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 9, 2009

First Posted

September 10, 2009

Study Start

July 1, 2009

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

November 25, 2010

Record last verified: 2009-11

Locations

US(1)