NCT03717935

Oral Amino Acid Nutrition to Improve Glucose Excursions in PCOS

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: Female
• Age: 12 Years – 21 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Essential Amino Acid (EAA) Supplement	Powder supplement
OTHER	Placebo	Powder that will be similar to the essential amino acid supplement

Timeline

• Start date: 2018-10-08
• Primary completion: 2022-01-14
• Completion: 2022-01-14
• First posted: 2018-10-24
• Last updated: 2025-03-24
• Results posted: 2025-03-24

Locations

1 site across 1 country: United States