Sarcopenia
Conditions
Keywords
muscle loss, protein, animal-based protein
Brief summary
A randomized study to demonstrate how animal-based protein-rich food sources can be used by older adults to increase protein intake within pre-existing dietary patterns.
Detailed description
Current dietary patterns of older Americans will be augmented by readily available quality protein sources. Investigators will observe the effects of recommended and common protein intakes on the maintenance of whole-body protein balance and potential for muscle protein anabolism. 3 groups of 10 older subjects will be studied during daily protein intakes. Study duration per subject will be about 2 weeks.
Interventions
OTHERRecommended Dietary Allowance of Protein
0.8 g/kg/day protein intake
OTHERHabitual protein intake
1.0 g/kg/day protein intake
OTHEROptimal Protein Intake
1.5 g/kg/day protein intake
Sponsors
University of Arkansas
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* BMI ≤ 35 kg/m2 * Capable of providing informed consent * COVID-19 negative and/or asymptomatic
Exclusion criteria
* Subject who does not/will not eat animal protein sources. * Body mass index \> 35. * History of chemotherapy or radiation therapy for cancer in the 6 months prior to enrollment. * Use of insulin to control blood sugar level. * Currently receiving androgen (e.g., testosterone) or anabolic (e.g., GH, IGF-I) therapy. * Currently using prescription blood thinning medications. * Unable or unwilling to suspend aspirin use for 7 days prior to Visit 3. * Unwilling to avoid using protein or amino-acid supplements during participation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Whole Body Protein Turnover | 24 hour | Isotope Tracer |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Recommended Dietary Allowance (RDA) for Protein (RDA; 0.8g/kg/day) Protein intakes will be structured within two meals per day. A 2-day dietary lead-in will precede each dietary intervention. Study duration per subject will last about two weeks.
Recommended Dietary Allowance of Protein: 0.8 g/kg/day protein intake | 10 |
| Habitual Protein Intake Consistent With Population Level Norms (NHANES; 1.0g/kg/day) Protein intakes will be structured within two meals per day. A 2-day dietary lead-in will precede each dietary intervention. Study duration per subject will last about two weeks.
Habitual protein intake: 1.0 g/kg/day protein intake | 11 |
| Optimal Protein Intake (OPI) (OPI; 1.5g/kg/day) Protein intakes will be structured within two meals per day. A 2-day dietary lead-in will precede each dietary intervention. Study duration per subject will last about two weeks.
Optimal Protein Intake: 1.5 g/kg/day protein intake | 9 |
| Total | 30 |
Baseline characteristics
| Characteristic | Recommended Dietary Allowance (RDA) for Protein | Habitual Protein Intake Consistent With Population Level Norms | Optimal Protein Intake (OPI) | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 3 Participants | 0 Participants | 6 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants | 8 Participants | 9 Participants | 24 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants | 11 Participants | 9 Participants | 30 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants | 2 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 | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 9 Participants | 10 Participants | 7 Participants | 26 Participants |
| Region of Enrollment United States | 10 participants | 11 participants | 9 participants | 30 participants |
| Sex: Female, Male Female | 5 Participants | 6 Participants | 6 Participants | 17 Participants |
| Sex: Female, Male Male | 5 Participants | 5 Participants | 3 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 14 | 0 / 12 |
| other Total, other adverse events | 6 / 18 | 3 / 14 | 5 / 12 |
| serious Total, serious adverse events | 1 / 18 | 0 / 14 | 0 / 12 |
Outcome results
Primary
Whole Body Protein Turnover
Isotope Tracer
Time frame: 24 hour
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Recommended Dietary Allowance (RDA) for Protein | Whole Body Protein Turnover | -0.16 g/kg lean body mass/day | Standard Deviation 0.08 |
| Habitual Protein Intake Consistent With Population Level Norms | Whole Body Protein Turnover | -0.17 g/kg lean body mass/day | Standard Deviation 0.11 |
| Optimal Protein Intake (OPI) | Whole Body Protein Turnover | 0.48 g/kg lean body mass/day | Standard Deviation 0.11 |