Nutritional Biomarkers of Sarcopenia

NCT ID: NCT05117112

Last Updated: 2024-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-08
• Study Completion Date: 2023-01-12

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.

Detailed Description

Sarcopenia increases the risk of a number of deleterious health conditions and represents a major financial cost to our healthcare system. Among older adults who are hospitalized, those with sarcopenia on admission are 5-fold more likely to incur higher hospital costs than those without. The operational definition of sarcopenia is defined as meeting the criteria for all of the following: low muscle strength, low muscle quantity or quality, and low physical performance. The diagnosis of sarcopenia requires techniques that are both expensive and operator-dependent. Simple measurements, such as BMI, do not necessarily identify sarcopenia. Importantly, current techniques can only identify sarcopenia after a physical/functional impairment has occurred. Skeletal muscle amino acid kinetics predict muscle health and functionality. Altered amino acid kinetics lead to decrements in muscle mass, quality, and performance. Muscle response to circulating essential amino acids (EAA) determines muscle amino acid kinetics. Thus, 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

10g of nutritional product

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

Group Type: EXPERIMENTAL

XS Muscle Multiplier

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

XS Muscle Multiplier

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

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Arkansas

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David D Church, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Arkansas

Locations

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

262590

Identifier Type: -

Identifier Source: org_study_id