N/A
N=23
Oral Amino Acid Nutrition to Improve Glucose Excursions in PCOS
Polycystic Ovarian Syndrome · Obesity · Hepatic Steatosis
Bottom Line
View on ClinicalTrials.gov: NCT03717935 ↗Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcome: Primary: Hepatic Fat Fraction — 8; 7.3 percent hepatic fat
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Essential Amino Acid (EAA) Supplement (Dietary_supplement); Placebo (Other)
- Age
- Pediatric, Adult · 12+ yrs
- Sex
- Female
- Sponsor
- University of Colorado, Denver
- Primary completion
- Jan 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hepatic Fat Fraction |
8; 7.3 | — |
| SECONDARY Rate of De Novo Lipogenesis |
9.60; 6.55 | — |
| SECONDARY Evaluation of Mitochondrial Function |
82.4; 82.5 | — |
| SECONDARY Hepatic Phosphate Profile After EAA and Placebo Supplement |
0.19670949; 0.186460069; 0.073640887; 0.074795509; 0.561426026; 0.564456782 | — |
| SECONDARY Whole Body Insulin Sensitivity |
0.00026; 0.00025 | — |
| SECONDARY Change in Adipose Insulin Sensitivity |
91.15; 91.11 | — |
| SECONDARY Sleep Duration |
390; 340.7 | — |
| SECONDARY Apnea Hypopnea Index (AHI) |
14.99; 17.04 | — |
| SECONDARY Amino Acid Metabolomics: Alanine, Glutamate, Leucine, Valine Levels After 4 Weeks of Placebo and 4 Weeks of EAAs |
420; 49; 91; 303; 385; 54 | — |
| SECONDARY Lipid Metabolomics: 16n1 |
87; 88 | — |
| SECONDARY Bile Acid Metabolomics: Sphingosine-1-phospate After 4 Weeks of Placebo and 4 Weeks of EAAs |
1334; 1294 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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)
Exclusion Criteria
- 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 125 IU/L
Data sourced from ClinicalTrials.gov (NCT03717935). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.