Nutritional Biomarkers of Sarcopenia

Sarcopenia Clinical Trial

Official title:

Nutritional Biomarkers of Sarcopenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05117112
• Other study ID #: 262590
• Status: Completed
• Phase: N/A
• Start date: April 8, 2022
• Est. completion date: January 12, 2023

Study information

• Verified date: February 2023
• Source: University of Arkansas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 12, 2023
• Est. primary completion date: January 12, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

Inclusion Criteria:

• Ages 18 - 30 and 70-89 yrs

• For the sarcopenic group, a SARC-F score of = 4 at the screening visit

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

Related Conditions & MeSH terms

• Sarcopenia

Intervention

Dietary Supplement:
• XS Muscle Multiplier
Distributed by Amway; this product is a powder, sold in a 6.8 ounce (192g) container.

Locations

Country	Name	City	State
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Arkansas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum plasma leucine concentration.		A 5-hour period.