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Clinical Trials/NCT03530774
NCT03530774
Completed
Not Applicable

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

The University of Texas at San Antonio1 site in 1 country54 target enrollmentMay 31, 2017
ConditionsSarcopeniaAging

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sarcopenia
Sponsor
The University of Texas at San Antonio
Enrollment
54
Locations
1
Primary Endpoint
Muscle Strength
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 31, 2017
End Date
August 31, 2018
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sarah Ullevig

Assistant Professor

The University of Texas at San Antonio

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Muscle Strength

Time Frame: Change from Baseline Muscle Strength at 6 months

Hand Dynamometer

Short physical performance battery (SPPB)

Time Frame: 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 mass

Time Frame: Change from Baseline Muscle Mass at 6 months

Dual-energy X-ray absorptimetry

Secondary Outcomes

  • Cognitive Function(Change from Baseline Cognitive Function at 6 months)
  • Protein intake(Change from Baseline Protein Intake at 6 months)
  • Upper Respiratory Illnesses Frequency(Change From Baseline Upper Respiratory Illness Frequency at 6 months)
  • Functional Limitations and Disability(Change From Baseline Functional Limitations and Disability at 6 months)
  • Health-Related Quality of Life(Change from Baseline Health-Related Quality of Life at 6 months)
  • Falls Risk(Change From Baseline Falls Efficacy and Frequency at 6 months)

Study Sites (1)

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