Nutritional Biomarkers of Sarcopenia
Primary Purpose
Sarcopenia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
XS Muscle Multiplier
Sponsored by
About this trial
This is an interventional screening trial for Sarcopenia
Eligibility Criteria
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
Sites / Locations
- University of Arkansas for Medical Sciences
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
10g of nutritional product
Arm Description
All subjects will ingest 10g of a commercially available nutritional supplement one time during a study visit.
Outcomes
Primary Outcome Measures
Maximum plasma leucine concentration.
Secondary Outcome Measures
Full Information
NCT ID
NCT05117112
First Posted
November 1, 2021
Last Updated
February 13, 2023
Sponsor
University of Arkansas
1. Study Identification
Unique Protocol Identification Number
NCT05117112
Brief Title
Nutritional Biomarkers of Sarcopenia
Official Title
Nutritional Biomarkers of Sarcopenia
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
April 8, 2022 (Actual)
Primary Completion Date
January 12, 2023 (Actual)
Study Completion Date
January 12, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arkansas
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Three groups of subjects will be studied: young/health, older/healthy, and older/sarcopenic.
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
10g of nutritional product
Arm Type
Experimental
Arm Description
All subjects will ingest 10g of a commercially available nutritional supplement one time during a study visit.
Intervention Type
Dietary Supplement
Intervention Name(s)
XS Muscle Multiplier
Intervention Description
Distributed by Amway; this product is a powder, sold in a 6.8 ounce (192g) container.
Primary Outcome Measure Information:
Title
Maximum plasma leucine concentration.
Time Frame
A 5-hour period.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David D Church, Ph.D.
Organizational Affiliation
University of Arkansas
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Nutritional Biomarkers of Sarcopenia
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