N/A Completed N=30 Screening

Nutritional Biomarkers of Sarcopenia

Sarcopenia

Source: ClinicalTrials.gov NCT05117112 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2024

Primary outcomePrimary: Resting and Maximum Plasma Leucine Concentration — 659; 755; 721; 95 micromoles per liter

Summary

This study proposes to characterize skeletal muscle amino acid kinetics to an EAA challenge, i.e., an oral amino acid tolerance test (OATT), in order to determine the state of muscle health. Analogous to the oral glucose tolerance test (OGTT) used to characterize alterations in glucose metabolism, the proposed OATT represents a potential low-cost solution to classifying patients' skeletal muscle health. The extrapolation of this work is the development of a simple analytical tool that would provide clinicians the ability to discern alterations in muscle amino acid kinetics prior to a loss of function.

Outcome Measures

Outcome	Result	p-value
PRIMARY Resting and Maximum Plasma Leucine Concentration	659; 755; 721; 95; 100; 100	—

Eligibility Criteria

Inclusion Criteria

Ages 18 - 30 and 70-89 yrs

Exclusion Criteria

History of diabetes that requires insulin for control of blood glucose
History of malignancy or chemo/radiation therapy in the 6 months prior to enrollment
History of gastrointestinal bypass/reduction surgery (Lapband, gastric sleeve, etc.)
Pregnant females
Unwilling to wear the breath-collection mask
Subjects who cannot refrain from using protein or amino acid supplements for 7 days prior to Visit 2
Concomitant use of oral or injectable corticosteroids
Concomitant use of testosterone, IGF-1, or similar anabolic agent
Any other disease or condition that would place the subject at increased risk of harm if they were to participate, at the discretion of the study physician

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05117112). 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. Informational only — not medical advice.