Oral Amino Acid Nutrition to Improve Glucose Excursions in PCOS

NCT ID: NCT03717935

Last Updated: 2025-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-08
• Study Completion Date: 2022-01-14

Brief Summary

The Investigators will measure hepatic glucose and fat metabolism in obese girls with Polycystic Ovarian Syndrome (PCOS) and hepatic steatosis (HS) after taking 4 weeks of an essential amino acid (EAA) supplement or placebo and test whether the EAA supplement can improve hepatic glucose metabolism in these girls.

Detailed Description

Girls with Polycystic Ovarian Syndrome (PCOS) and hepatic steatosis (HS) will complete a 12 week double-blinded placebo controlled cross-over study with 4 weeks each of an essential amino acid (EAA) supplement and placebo, and will complete metabolic studies after each intervention. There will be a 4 week wash out period in-between. The metabolic tests after each intervention (EAA/placebo) will include an oral sugar tolerance test (OSTT) and an oral U-C13 glycerol tracer that is paired with Nuclear Magnetic Resonance (NMR) isotopomer analysis of serum samples to describe flux through the hepatic pentose phosphate pathway, tricarboxylic acid (TCA) cycle and fatty acid synthesis pathways in girls with PCOS and HS. Hepatic steatosis will be measured with magnetic resonance Imaging (MRI) and hepatic phosphate concentrations with magnetic resonance (MR) spectroscopy.

Conditions

Polycystic Ovarian Syndrome; Obesity; Hepatic Steatosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Essential Amino Acid (EAA) Supplement

4 weeks: Essential Amino Acid Supplement- 15g 2/day

Group Type: EXPERIMENTAL

Essential Amino Acid (EAA) Supplement

Intervention Type: DIETARY_SUPPLEMENT

Powder supplement

Placebo

Intervention Type: OTHER

Powder that will be similar to the essential amino acid supplement

Placebo

4 weeks: Placebo- 15g 2/day

Group Type: PLACEBO_COMPARATOR

Essential Amino Acid (EAA) Supplement

Intervention Type: DIETARY_SUPPLEMENT

Powder supplement

Placebo

Intervention Type: OTHER

Powder that will be similar to the essential amino acid supplement

Interventions

Essential Amino Acid (EAA) Supplement

Powder supplement

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Powder that will be similar to the essential amino acid supplement

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Females

2. Ages 12-21

3. Sedentary- less than 2 hours of moderate (jogging, swimming etc) exercise a week.

4. BMI equal or greater than the 90th percentile for age and gender

5. PCOS per the most stringent NIH criteria adapted for adolescents (irregular menses >24 months post-menarche and clinical or biochemical hypertestosteronemia)

6. HS per FibroScan ultrasound, with CAP score of >225 (will be measured at screening visit)

Exclusion Criteria

1. Use of medications known to affect insulin sensitivity: metformin, oral glucocorticoids within 10 days, atypical antipsychotics, immunosuppressant agents, HIV medications, hormonal contraception. Dermal patch or vaginal ring contraception methods.

2. Currently pregnant or breastfeeding women. Development of pregnancy during the study period will necessitate withdrawal from the study.

3. Severe illness requiring hospitalization within 60 days

4. Diabetes, defined as Hemoglobin A1C > 6.4%

5. BMI percentile less than the 90th percentile for age and sex. Weight >325 lbs or <84 lbs.

6. Anemia, defined as Hemoglobin < 11 mg/dL

7. Diagnosed major psychiatric or developmental disorder limiting informed consent

8. Implanted metal devices that are not compatible with MRI

9. Use of blood pressure medications

10. Known liver disease other than NAFLD or AST or ALT >125 IU/L

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Melanie Cree-Green, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Endocrinology

Locations

University of Colorado, Anschutz Medical Campus

Aurora, Colorado, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

18-0803

Identifier Type: -

Identifier Source: org_study_id