N/A
N=30
Nutritional Biomarkers of Sarcopenia
Sarcopenia
Bottom Line
View on ClinicalTrials.gov: NCT05117112 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcome: Primary: Resting and Maximum Plasma Leucine Concentration — 659; 755; 721; 95 micromoles per liter
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- XS Muscle Multiplier (Dietary_supplement)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Arkansas
- Primary completion
- Jan 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Resting and Maximum Plasma Leucine Concentration |
659; 755; 721; 95; 100; 100 | — |
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.
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
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.