Supplemental Egg Protein Intervention In Older Adults

Study Overview
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Brief Summary
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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
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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.

Official Title
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Egg Protein Supplementation for Maintaining Muscle Mass and Function in Older Adults

Conditions
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Sarcopenia, Aging

Intervention / Treatment
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* Dietary Supplement: powdered egg white protein supplement
* Dietary Supplement: maltodextrin supplement


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Egg while protein supplement<br>25 g of powdered egg white protein supplement daily for 6 months. Total of 20.6 g of protein in 25 g of supplement. | Dietary Supplement: powdered egg white protein supplement<br>* consumption of egg white protein supplement daily for 6 months<br>|
| Placebo Comparator: Maltodextrin supplement<br>25 g of powdered maltodextrin supplement daily for 6 months. Total 23.5 g of carbohydrate in 25 g of supplement. | Dietary Supplement: maltodextrin supplement<br>* consumption of maltodextrin supplement daily for 6 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle mass | Dual-energy X-ray absorptimetry | Change from Baseline Muscle Mass at 6 months | 
| Short physical performance battery (SPPB) | 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. | Change from Baseline Physical Function at 6 months | 
| Muscle Strength | Hand Dynamometer | Change from Baseline Muscle Strength at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Protein intake | 24-hour recalls (2 non-consecutive) | Change from Baseline Protein Intake at 6 months | 
| Health-Related Quality of Life | Short Form 12 Health Survey | Change from Baseline Health-Related Quality of Life at 6 months | 
| Upper Respiratory Illnesses Frequency | Daily illness log | Change From Baseline Upper Respiratory Illness Frequency at 6 months | 
| Cognitive Function | Trail Making Test A and B | Change from Baseline Cognitive Function at 6 months | 
| Falls Risk | 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 | Change From Baseline Falls Efficacy and Frequency at 6 months | 
| Functional Limitations and Disability | 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. | Change From Baseline Functional Limitations and Disability at 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dual-energy X-ray absorptimetry, dietary supplement, protein, physical performance battery, 24-hour dietary recalls