NCT05117112

Nutritional Biomarkers of Sarcopenia

Completed NA Results posted Last updated 25 September 2024

What this trial tests

NA trial testing XS Muscle Multiplier in Sarcopenia in 30 participants. Completed in 12 January 2023.

Timeline

8 April 2022

Primary endpoint
12 January 2023

12 January 2023

Quick facts

Lead sponsor	University of Arkansas
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	screening
Enrollment	30
Start date	8 April 2022
Primary completion	12 January 2023
Estimated completion	12 January 2023
Sites	1 location across United States

Drugs / interventions tested

• XS Muscle Multiplier

Conditions studied

• Sarcopenia — all drugs for Sarcopenia →

Sponsor

University of Arkansas

Who can join

Adults 18 to 89, any sex, with Sarcopenia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Resting and Maximum Plasma Leucine Concentration Primary · A 5-hour period.

The amount of leucine in the plasma at rest, following an overnight fast. Then maximum concentration of plasma leucine was the higher concentration observed following ingestion of the drink. The maximum amount can be different for everyone but typically occurs 45 to 75 minutes after consumption of the amino acid drink

Max Plasma Leucine Concentration

Group	Value	95% CI
Healthy Young	659	± 128
Healthy Elderly	755	± 67
Sarcopenic Elderly	721	± 114

Resting Plasma Leucine Concentration

Group	Value	95% CI
Healthy Young	95	± 21
Healthy Elderly	100	± 22
Sarcopenic Elderly	100	± 21

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Effects of acute essential amino acid intake on post-prandial raw bioimpedance and fluid shifts between healthy young and older adults: An exploratory pilot study.
   Unrein CL, Church DD, Ferrando AA, Wolfe RR, et al · · 2025 · PMID 41355947 · DOI 10.2478/joeb-2025-0016