Oral Amino Acid Nutrition to Improve Glucose Excursions in PCOS

NCT03717935 | Completed Results

• 1 other identifier: 18-0803
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Polycystic Ovarian Syndrome; Obesity; Hepatic Steatosis

Keywords

hepatic de novo lipogenesis

Outcome Measures

Primary Outcomes (1)

• Hepatic Fat Fraction

  Hepatic Fat Fraction measured after completing placebo and amino acid therapy measured with MRI, and calculated via the Dixon method as the proton density hepatic fat fraction, which ranges from 0-75%. Greater than 5% is considered extra fat

  4 weeks after completing the first intervention, and approximately 8 weeks later (4 weeks washout and 4 weeks of second intervention)

Secondary Outcomes (10)

• Rate of De Novo Lipogenesis

  4 weeks after the first intervention, and approximately 8 weeks later (4 weeks washout and 4 weeks of second intervention)

• Evaluation of Mitochondrial Function

  4 weeks after the first intervention, and approximately 8 weeks later (4 weeks washout and 4 weeks of second intervention)

• Hepatic Phosphate Profile After EAA and Placebo Supplement

  4 weeks after the first intervention, and approximately 8 weeks later (4 weeks washout and 4 weeks of second intervention)

• Whole Body Insulin Sensitivity

  4 weeks after the first intervention, and approximately 8 weeks later (4 weeks washout and 4 weeks of second intervention)

• Change in Adipose Insulin Sensitivity

  4 weeks after the first intervention, and approximately 8 weeks later (4 weeks washout and 4 weeks of second intervention)

Study Arms (2)

Essential Amino Acid (EAA) Supplement

EXPERIMENTAL

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

Dietary Supplement: Essential Amino Acid (EAA) Supplement; Other: Placebo

Placebo

PLACEBO COMPARATOR

4 weeks: Placebo- 15g 2/day

Dietary Supplement: Essential Amino Acid (EAA) Supplement; Other: Placebo

Interventions

Essential Amino Acid (EAA) Supplement DIETARY_SUPPLEMENT

Powder supplement

Essential Amino Acid (EAA) Supplement; Placebo

Placebo OTHER

Powder that will be similar to the essential amino acid supplement

Essential Amino Acid (EAA) Supplement; Placebo

Eligibility Criteria

• Age: 12 Years - 21 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Females
• Ages 12-21
• Sedentary- less than 2 hours of moderate (jogging, swimming etc) exercise a week.
• BMI equal or greater than the 90th percentile for age and gender
• PCOS per the most stringent NIH criteria adapted for adolescents (irregular menses \>24 months post-menarche and clinical or biochemical hypertestosteronemia)
• HS per FibroScan ultrasound, with CAP score of \>225 (will be measured at screening visit)

You may not qualify if:

• 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.
• Currently pregnant or breastfeeding women. Development of pregnancy during the study period will necessitate withdrawal from the study.
• Severe illness requiring hospitalization within 60 days
• Diabetes, defined as Hemoglobin A1C \> 6.4%
• BMI percentile less than the 90th percentile for age and sex. Weight \>325 lbs or \<84 lbs.
• Anemia, defined as Hemoglobin \< 11 mg/dL
• Diagnosed major psychiatric or developmental disorder limiting informed consent
• Implanted metal devices that are not compatible with MRI
• Use of blood pressure medications
• Known liver disease other than NAFLD or AST or ALT \>125 IU/L

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado, Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Obesity; Fatty Liver

Interventions

Amino Acids, Essential; Excitatory Amino Acids

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Melanie Cree-Green, PI
• Organization: University of Colorado

melanie.green@childrenscolorado.org

720-777-5743

Study Officials

• Melanie Cree-Green, MD, PhD

  Department of Endocrinology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigational drug pharmacy will performed randomization and dispense the EAA or placebo.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2018
• First Posted: October 24, 2018
• Study Start: October 8, 2018
• Primary Completion: January 14, 2022
• Study Completion: January 14, 2022
• Last Updated: March 24, 2025
• Results First Posted: March 24, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)