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Clinical Trials/NCT03530774
NCT03530774CompletedNot 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 enrollmentStarted: May 31, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
54
Locations
1
Primary Endpoint
Short physical performance battery (SPPB)

Study 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Masking Description

Participants will be blinded to control (carbohydrate) or egg white protein supplement

Eligibility Criteria

Ages
60 Years to — (Adult, Older Adult)
Sex
All
Accepts 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.

Arms & Interventions

Egg while protein supplement

Experimental

25 g of powdered egg white protein supplement daily for 6 months. Total of 20.6 g of protein in 25 g of supplement.

Intervention: powdered egg white protein supplement (Dietary Supplement)

Maltodextrin supplement

Placebo Comparator

25 g of powdered maltodextrin supplement daily for 6 months. Total 23.5 g of carbohydrate in 25 g of supplement.

Intervention: maltodextrin supplement (Dietary Supplement)

Outcomes

Primary Outcomes

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

Muscle Strength

Time Frame: Change from Baseline Muscle Strength at 6 months

Hand Dynamometer

Secondary Outcomes

  • Protein intake(Change from Baseline Protein Intake at 6 months)
  • Upper Respiratory Illnesses Frequency(Change From Baseline Upper Respiratory Illness Frequency at 6 months)
  • Cognitive Function(Change from Baseline Cognitive Function 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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Sarah Ullevig

Assistant Professor

The University of Texas at San Antonio

Study Sites (1)

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