Clinical trial NCT03530774: Supplemental Egg Protein Intervention in Older Adults
Official title: Egg Protein Supplementation for Maintaining Muscle Mass and Function in Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sarcopenia
Aging
Keywords: physical performance battery
24-hour dietary recalls
dual-energy X-ray absorptimetry
dietary supplement
protein
Lead sponsor: The University of Texas at San Antonio
Sponsor class: OTHER
Collaborators: name: Texas State University
name: American Egg Board
First posted: 2018-05-21
Enrollment: 54
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Muscle mass
timeFrame: Change from Baseline Muscle Mass at 6 months
measure: Short physical performance battery (SPPB)
timeFrame: Change from Baseline Physical Function at 6 months
measure: Muscle Strength
timeFrame: Change from Baseline Muscle Strength at 6 months
Secondary outcomes:
measure: Protein intake
timeFrame: Change from Baseline Protein Intake at 6 months
measure: Health-Related Quality of Life
timeFrame: Change from Baseline Health-Related Quality of Life at 6 months
measure: Upper Respiratory Illnesses Frequency
timeFrame: Change From Baseline Upper Respiratory Illness Frequency at 6 months
measure: Cognitive Function
timeFrame: Change from Baseline Cognitive Function at 6 months
measure: Falls Risk
timeFrame: Change From Baseline Falls Efficacy and Frequency at 6 months
measure: Functional Limitations and Disability
timeFrame: Change From Baseline Functional Limitations and Disability at 6 months
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: University of Texas at San Antonio
state: Texas
Study officials:
affiliation: University of Texas at San Antonio
name: Sarah L Ullevig, PhD, RD
role: PRINCIPAL_INVESTIGATOR
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