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Completed

NCT Number: NCT03530774

Supplemental Egg Protein Intervention 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.

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Key information

Conditions

Sarcopenia Aging Atrophy Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Texas at San Antonio

San Antonio, Texas, 78249, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

powdered egg white protein supplement

Dietary Supplement

consumption of egg white protein supplement daily for 6 months

Maltodextrin supplement

Dietary Supplement

consumption of maltodextrin supplement daily for 6 months

Primary outcomes

  1. Muscle mass

    Time frame: Change from Baseline Muscle Mass at 6 months

    Dual-energy X-ray absorptimetry

  2. 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.

  3. Muscle Strength

    Time frame: Change from Baseline Muscle Strength at 6 months

    Hand Dynamometer

Secondary outcomes

  1. Protein intake

    Time frame: Change from Baseline Protein Intake at 6 months

    24-hour recalls (2 non-consecutive)

  2. Health-Related Quality of Life

    Time frame: Change from Baseline Health-Related Quality of Life at 6 months

    Short Form 12 Health Survey

  3. Upper Respiratory Illnesses Frequency

    Time frame: Change From Baseline Upper Respiratory Illness Frequency at 6 months

    Daily illness log

  4. Cognitive Function

    Time frame: Change from Baseline Cognitive Function at 6 months

    Trail Making Test A and B

  5. 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

  6. 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.

Sponsors and collaborators

Lead sponsor

The University of Texas at San Antonio

Other

Collaborators

  • American Egg Board
  • Texas State University

Registry information

Official study title

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

Acronym: SPRI

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 21, 2018
Registry last updated
Dec 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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