Nutritional Biomarkers of Sarcopenia

NCT05117112 | Completed Results

• 1 other identifier: 262590
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sarcopenia

Outcome Measures

Primary Outcomes (1)

• Resting and Maximum Plasma Leucine Concentration

  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

  A 5-hour period.

Study Arms (1)

10g of nutritional product

EXPERIMENTAL

All subjects will ingest 10g of a commercially available nutritional supplement one time during a study visit.

Dietary Supplement: XS Muscle Multiplier

Interventions

XS Muscle Multiplier DIETARY_SUPPLEMENT

Distributed by Amway; this product is a powder, sold in a 6.8 ounce (192g) container.

10g of nutritional product

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ages 18 - 30 and 70-89 yrs

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Arkansas: lead

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Results Point of Contact

• Title: David Church
• Organization: UAMS

dchurch@uams.edu

5015265769

Study Officials

• David D Church, Ph.D.

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Three groups of subjects will be studied: young/health, older/healthy, and older/sarcopenic.

Study Record Dates

• First Submitted: November 1, 2021
• First Posted: November 11, 2021
• Study Start: April 8, 2022
• Primary Completion: January 12, 2023
• Study Completion: January 12, 2023
• Last Updated: September 25, 2024
• Results First Posted: September 25, 2024

Record last verified: 2023-02

Locations

US (1)