Supplemental Egg Protein Intervention In Older Adults (SPRI)
Primary Purpose
Sarcopenia, Aging
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
powdered egg white protein supplement
maltodextrin supplement
Sponsored by
About this trial
This is an interventional supportive care trial for Sarcopenia focused on measuring physical performance battery, 24-hour dietary recalls, dual-energy X-ray absorptimetry, dietary supplement, protein
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.
Sites / Locations
- University of Texas at San Antonio
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Egg while protein supplement
Maltodextrin supplement
Arm Description
25 g of powdered egg white protein supplement daily for 6 months. Total of 20.6 g of protein in 25 g of supplement.
25 g of powdered maltodextrin supplement daily for 6 months. Total 23.5 g of carbohydrate in 25 g of supplement.
Outcomes
Primary Outcome Measures
Muscle mass
Dual-energy X-ray absorptimetry
Short physical performance battery (SPPB)
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 Strength
Hand Dynamometer
Secondary Outcome Measures
Protein intake
24-hour recalls (2 non-consecutive)
Health-Related Quality of Life
Short Form 12 Health Survey
Upper Respiratory Illnesses Frequency
Daily illness log
Cognitive Function
Trail Making Test A and B
Falls Risk
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
Functional Limitations and Disability
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.
Full Information
NCT ID
NCT03530774
First Posted
October 13, 2017
Last Updated
November 2, 2020
Sponsor
The University of Texas at San Antonio
Collaborators
Texas State University, American Egg Board
1. Study Identification
Unique Protocol Identification Number
NCT03530774
Brief Title
Supplemental Egg Protein Intervention In Older Adults
Acronym
SPRI
Official Title
Egg Protein Supplementation for Maintaining Muscle Mass and Function in Older Adults
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
May 31, 2017 (Actual)
Primary Completion Date
August 31, 2018 (Actual)
Study Completion Date
August 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas at San Antonio
Collaborators
Texas State University, American Egg Board
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia, Aging
Keywords
physical performance battery, 24-hour dietary recalls, dual-energy X-ray absorptimetry, dietary supplement, protein
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Participants will be blinded to control (carbohydrate) or egg white protein supplement
Allocation
Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Egg while protein supplement
Arm Type
Experimental
Arm Description
25 g of powdered egg white protein supplement daily for 6 months. Total of 20.6 g of protein in 25 g of supplement.
Arm Title
Maltodextrin supplement
Arm Type
Placebo Comparator
Arm Description
25 g of powdered maltodextrin supplement daily for 6 months. Total 23.5 g of carbohydrate in 25 g of supplement.
Intervention Type
Dietary Supplement
Intervention Name(s)
powdered egg white protein supplement
Intervention Description
consumption of egg white protein supplement daily for 6 months
Intervention Type
Dietary Supplement
Intervention Name(s)
maltodextrin supplement
Intervention Description
consumption of maltodextrin supplement daily for 6 months
Primary Outcome Measure Information:
Title
Muscle mass
Description
Dual-energy X-ray absorptimetry
Time Frame
Change from Baseline Muscle Mass at 6 months
Title
Short physical performance battery (SPPB)
Description
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.
Time Frame
Change from Baseline Physical Function at 6 months
Title
Muscle Strength
Description
Hand Dynamometer
Time Frame
Change from Baseline Muscle Strength at 6 months
Secondary Outcome Measure Information:
Title
Protein intake
Description
24-hour recalls (2 non-consecutive)
Time Frame
Change from Baseline Protein Intake at 6 months
Title
Health-Related Quality of Life
Description
Short Form 12 Health Survey
Time Frame
Change from Baseline Health-Related Quality of Life at 6 months
Title
Upper Respiratory Illnesses Frequency
Description
Daily illness log
Time Frame
Change From Baseline Upper Respiratory Illness Frequency at 6 months
Title
Cognitive Function
Description
Trail Making Test A and B
Time Frame
Change from Baseline Cognitive Function at 6 months
Title
Falls Risk
Description
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
Time Frame
Change From Baseline Falls Efficacy and Frequency at 6 months
Title
Functional Limitations and Disability
Description
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.
Time Frame
Change From Baseline Functional Limitations and Disability at 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah L Ullevig, PhD, RD
Organizational Affiliation
University of Texas at San Antonio
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78249
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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14684391
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Supplemental Egg Protein Intervention In Older Adults
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