Sarcopenia
Conditions
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.
Interventions
DIETARY_SUPPLEMENTXS Muscle Multiplier
Distributed by Amway; this product is a powder, sold in a 6.8 ounce (192g) container.
Sponsors
University of Arkansas
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Intervention model description
Three groups of subjects will be studied: young/health, older/healthy, and older/sarcopenic.
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Resting and Maximum Plasma Leucine Concentration | A 5-hour period. | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Healthy Young 18 to 30 years old. | 9 |
| Healthy Elderly Greater than or equal to 70 years of age. Handgrip greater than 35.5 and 20 for men and women, respectively. | 10 |
| Sarcopenic Elderly Greater than or equal to 70 years of age. Handgrip less than 35.5 and 20 for men and women, respectively. | 10 |
| Total | 29 |
Baseline characteristics
| Characteristic | Healthy Elderly | Sarcopenic Elderly | Total | Healthy Young |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 10 Participants | 10 Participants | 20 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 9 Participants | 9 Participants |
| Age, Continuous | 75.5 years STANDARD_DEVIATION 5.5 | 77.1 years STANDARD_DEVIATION 3.9 | 60.4 years STANDARD_DEVIATION 23.9 | 26.8 years STANDARD_DEVIATION 3.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 10 Participants | 10 Participants | 28 Participants | 8 Participants |
| Region of Enrollment United States | 10 Participants | 10 Participants | 29 Participants | 9 Participants |
| Sex: Female, Male Female | 9 Participants | 4 Participants | 21 Participants | 8 Participants |
| Sex: Female, Male Male | 1 Participants | 6 Participants | 8 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 9 | 0 / 11 | 0 / 10 |
| other Total, other adverse events | 0 / 9 | 0 / 11 | 0 / 10 |
| serious Total, serious adverse events | 0 / 9 | 0 / 11 | 0 / 10 |
Outcome results
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
Time frame: A 5-hour period.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Young | Resting and Maximum Plasma Leucine Concentration | Max Plasma Leucine Concentration | 659 micromoles per liter | Standard Deviation 128 |
| Healthy Young | Resting and Maximum Plasma Leucine Concentration | Resting Plasma Leucine Concentration | 95 micromoles per liter | Standard Deviation 21 |
| Healthy Elderly | Resting and Maximum Plasma Leucine Concentration | Max Plasma Leucine Concentration | 755 micromoles per liter | Standard Deviation 67 |
| Healthy Elderly | Resting and Maximum Plasma Leucine Concentration | Resting Plasma Leucine Concentration | 100 micromoles per liter | Standard Deviation 22 |
| Sarcopenic Elderly | Resting and Maximum Plasma Leucine Concentration | Max Plasma Leucine Concentration | 721 micromoles per liter | Standard Deviation 114 |
| Sarcopenic Elderly | Resting and Maximum Plasma Leucine Concentration | Resting Plasma Leucine Concentration | 100 micromoles per liter | Standard Deviation 21 |