Clinical trial · Interventional
Oral Amino Acid Nutrition to Improve Glucose Excursions in PCOS
NCT03717935CI-TRIAL-00087573ORANGEcompletedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatic Steatosis | — | UNRESOLVED | — |
| Obesity | — | UNRESOLVED | — |
| Polycystic Ovarian Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Essential Amino Acid (EAA) Supplement | Dietary Supplement | — | UNRESOLVED |
| Placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Essential Amino Acid (EAA) Supplement
- description
- 4 weeks: Essential Amino Acid Supplement- 15g 2/day
- interventionNames
- Dietary Supplement: Essential Amino Acid (EAA) Supplement
- Other: Placebo
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- 4 weeks: Placebo- 15g 2/day
- interventionNames
- Dietary Supplement: Essential Amino Acid (EAA) Supplement
- Other: Placebo
Primary outcomes (1)
- measure
- Hepatic Fat Fraction
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 12 Years
- Maximum age
- 21 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDBoster JM, Cree MG, Kelsey MM, Nadeau KJ, Chaidez A, Pan Z, Sundaram SS. Relative Skeletal Muscle Mass Is Associated With Hepatic Steatosis in Adolescents With Overweight and Obesity. Pediatr Obes. 2026 Apr;21(4):e70108. doi: 10.1111/ijpo.70108. PMID 42014131