Supplemental Egg Protein Intervention in Older Adults (SPRI)

December 17, 2024 updated by: Sarah Ullevig, The University of Texas at San Antonio

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • San Antonio, Texas, United States, 78249
        • University of Texas at San Antonio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Egg while protein supplement
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
consumption of egg white protein supplement daily for 6 months
Placebo Comparator: Maltodextrin supplement
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
consumption of maltodextrin supplement daily for 6 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscle mass
Time Frame: Change from Baseline Muscle Mass at 6 months
Dual-energy X-ray absorptimetry
Change from Baseline Muscle Mass at 6 months
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.
Change from Baseline Physical Function at 6 months
Muscle Strength
Time Frame: Change from Baseline Muscle Strength at 6 months
Hand Dynamometer
Change from Baseline Muscle Strength at 6 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas at San Antonio

Collaborators

Texas State University
American Egg Board

Investigators

  • Principal Investigator: Sarah L Ullevig, PhD, RD, University of Texas at San Antonio

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 31, 2017

Primary Completion (Actual)

August 31, 2018

Study Completion (Actual)

August 31, 2018

Study Registration Dates

First Submitted

October 13, 2017

First Submitted That Met QC Criteria

May 8, 2018

First Posted (Actual)

May 21, 2018

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 17, 2024

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-110

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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