Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 10g of nutritional product | Experimental | All subjects will ingest 10g of a commercially available nutritional supplement one time during a study visit. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XS Muscle Multiplier | Dietary Supplement | Distributed by Amway; this product is a powder, sold in a 6.8 ounce (192g) container. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| David D Church, Ph.D. | University of Arkansas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Healthy Young | 18 to 30 years old. |
| FG001 | Healthy Elderly | Greater than or equal to 70 years of age. Handgrip greater than 35.5 and 20 for men and women, respectively. |
| FG002 | Sarcopenic Elderly | Greater than or equal to 70 years of age. Handgrip less than 35.5 and 20 for men and women, respectively. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Healthy Young | 18 to 30 years old. |
| BG001 | Healthy Elderly | Greater than or equal to 70 years of age. Handgrip greater than 35.5 and 20 for men and women, respectively. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Mean | Standard Deviation | micromoles per liter | A 5-hour period. |
|
From enrollment to the completion of the study day. Approximately 2 weeks.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Healthy Young | 18 to 30 years old. | 0 |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Church | UAMS | 5015265769 | dchurch@uams.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 31, 2022 | Jun 14, 2024 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D055948 | Sarcopenia |
| ID | Term |
|---|---|
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Three groups of subjects will be studied: young/health, older/healthy, and older/sarcopenic.
Not provided
Not provided
Not provided
Not provided
| BG002 | Sarcopenic Elderly | Greater than or equal to 70 years of age. Handgrip less than 35.5 and 20 for men and women, respectively. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG002 |
| Sarcopenic Elderly |
Greater than or equal to 70 years of age. Handgrip less than 35.5 and 20 for men and women, respectively. |
|
|
| 9 |
| 0 |
| 9 |
| 0 |
| 9 |
| EG001 | Healthy Elderly | Greater than or equal to 70 years of age. Handgrip greater than 35.5 and 20 for men and women, respectively. | 0 | 11 | 0 | 11 | 0 | 11 |
| EG002 | Sarcopenic Elderly | Greater than or equal to 70 years of age. Handgrip less than 35.5 and 20 for men and women, respectively. | 0 | 10 | 0 | 10 | 0 | 10 |
Not provided
Not provided
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |