Aging, Sarcopenia
Conditions
Keywords
physical performance battery, 24-hour dietary recalls, dual-energy X-ray absorptimetry, dietary supplement, protein
Brief summary
Older adults are at risk for developing sarcopenia, or age-related muscle loss, which increased the risk of disabilities, falls, and loss of independence. Many older adults do not consume enough protein each day to maintain their muscle mass and this study aims to investigate if consumption daily egg white protein supplement can help maintain muscle mass and functionality in community-dwelling older adults. Food insecure older adults that attend congregate nutrition sites will be targeted.
Detailed description
The study aims to evaluate the impact of egg white protein supplementation on muscle mass, strength, and physical function in older adults with low muscle mass or function. Older adults will be recruited from San Antonio, Texas, the least food secure metropolitan area for older adults. The project will be conducted entirely at community locations such as congregate meal sites, senior activity centers, and housing communities. Researchers will conduct recruitment, distribution of supplements and pre and post assessments entirely at these sites, which will alleviate the travel of participants to research sites and provide a unique opportunity to assess this underserved population. One hundred older adults (≥60yrs old) will be randomly assigned to consume a daily supplement of egg white protein or isoenergetic carbohydrate for 6 months. Changes in skeletal muscle mass, muscle strength, and physical function will be assessed.
Interventions
DIETARY_SUPPLEMENTpowdered egg white protein supplement
consumption of egg white protein supplement daily for 6 months
DIETARY_SUPPLEMENTmaltodextrin supplement
consumption of maltodextrin supplement daily for 6 months
Sponsors
Texas State University
American Egg Board
The University of Texas at San Antonio
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Participants will be blinded to control (carbohydrate) or egg white protein supplement
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 60 years or older, gait speed \>0.8m/s OR hand grip below 20kg for women or below 30kg for men
Exclusion criteria
* Over 300 pounds, kidney disease, has taken a protein supplement within the past 30 days, dementia/Alzheimer's, uncontrolled diabetes, wheelchair bound, vegan, allergic to eggs, blind/legally blind, history of stroke/transient ischemic attack with a Barthel score of 15 or lower, cannot read or write English or Spanish and don't have someone to help them with forms/paperwork, not willing to take a supplement for 6 months or will not remain in the local area for the study period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Muscle mass | Change from Baseline Muscle Mass at 6 months | Dual-energy X-ray absorptimetry |
| Short physical performance battery (SPPB) | Change from Baseline Physical Function at 6 months | Includes objective, performance-based measures of balance (standing side by side, semi-tandem and tandem), mobility (4-m habitual gait speed), and strength (5 chair stands). Each task is scored from 0-4 Points (p) and then summed into a total score of 0 (worst)-12 (best) p, where 12 p represents the highest performance. |
| Muscle Strength | Change from Baseline Muscle Strength at 6 months | Hand Dynamometer |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cognitive Function | Change from Baseline Cognitive Function at 6 months | Trail Making Test A and B |
| Protein intake | Change from Baseline Protein Intake at 6 months | 24-hour recalls (2 non-consecutive) |
| Functional Limitations and Disability | Change From Baseline Functional Limitations and Disability at 6 months | The Late-Life Function and Disability Instrument is a validated questionnaire that measures both functional limitations and disability. The function component evaluates self-reported difficulty in performing 32 physical activities. Scores range from 0-100 with higher scores indicating higher levels of function. Disability component evaluates self-reported limitations and frequency of limitations in 16 activities. Scores range from 0-100 with higher scores indicating higher levels of function. |
| Falls Risk | Change From Baseline Falls Efficacy and Frequency at 6 months | A short questionnaire will be used to gather information on number of falls recalled over the past 6 months, whether the individual sought medical attention for any of the falls, and whether an injury resulted from any of the falls. The Falls Efficacy Scale is a 10 item scale assessing the confidence level individuals have in performing daily activities without falling. Each item is rated on a scale of 0-10, with 0 signifying no confidence and 10 indicating very confident. Scores are totaled and range from 0-100 with higher scores indicating greater confidence |
| Health-Related Quality of Life | Change from Baseline Health-Related Quality of Life at 6 months | Short Form 12 Health Survey |
| Upper Respiratory Illnesses Frequency | Change From Baseline Upper Respiratory Illness Frequency at 6 months | Daily illness log |
Countries
United States
Outcome results
None listed