Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
24 participants
INTERVENTIONAL
2009-07-31
2009-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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AA Drink
Amino Acid Drink Mixture
Amino Acid Drink Mixture
22 oz consumed in 7 oz, 8oz, 7 oz increments 5 minutes apart over 15 mins
Glucose drink
Glucose drink
22 oz consumed in 7 oz, 8oz, 7 oz increments 5 minutes apart over 15 mins
Interventions
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Amino Acid Drink Mixture
22 oz consumed in 7 oz, 8oz, 7 oz increments 5 minutes apart over 15 mins
Glucose drink
22 oz consumed in 7 oz, 8oz, 7 oz increments 5 minutes apart over 15 mins
Eligibility Criteria
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Inclusion Criteria
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
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.
20 Years
45 Years
ALL
Yes
Sponsors
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Abbott Nutrition
INDUSTRY
Responsible Party
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Abbott Nutrition
Principal Investigators
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Jeffrey Nelson, PhD
Role: STUDY_CHAIR
Abbott Nutrition
Locations
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University of Texas
Austin, Texas, United States
Countries
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Other Identifiers
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BK51
Identifier Type: -
Identifier Source: org_study_id