Supplemental Egg Protein Intervention In Older Adults

Aging Clinical Trial

— SPRI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03530774
• Other study ID #: 17-110
• Status: Completed
• Phase: N/A
• Start date: May 31, 2017
• Est. completion date: August 31, 2018

Study information

• Verified date: November 2020
• Source: The University of Texas at San Antonio
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: August 31, 2018
• Est. primary completion date: August 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aging
• Sarcopenia

Intervention

Dietary Supplement:
• powdered egg white protein supplement
consumption of egg white protein supplement daily for 6 months
• maltodextrin supplement
consumption of maltodextrin supplement daily for 6 months

Locations

Country	Name	City	State
United States	University of Texas at San Antonio	San Antonio	Texas

Sponsors (3)

Lead Sponsor	Collaborator
The University of Texas at San Antonio	American Egg Board, Texas State University

Country where clinical trial is conducted

United States, 

References & Publications (9)

Ali S, Garcia JM. Sarcopenia, cachexia and aging: diagnosis, mechanisms and therapeutic options - a mini-review. Gerontology. 2014;60(4):294-305. doi: 10.1159/000356760. Epub 2014 Apr 8. Review. — View Citation

Best RL, Appleton KM. The consumption of protein-rich foods in older adults: an exploratory focus group study. J Nutr Educ Behav. 2013 Nov-Dec;45(6):751-5. doi: 10.1016/j.jneb.2013.03.008. Epub 2013 Jul 2. — View Citation

Cruz-Jentoft AJ, Baeyens JP, Bauer JM, Boirie Y, Cederholm T, Landi F, Martin FC, Michel JP, Rolland Y, Schneider SM, Topinková E, Vandewoude M, Zamboni M; European Working Group on Sarcopenia in Older People. Sarcopenia: European consensus on definition and diagnosis: Report of the European Working Group on Sarcopenia in Older People. Age Ageing. 2010 Jul;39(4):412-23. doi: 10.1093/ageing/afq034. Epub 2010 Apr 13. — View Citation

Cruz-Jentoft AJ, Landi F, Schneider SM, Zúñiga C, Arai H, Boirie Y, Chen LK, Fielding RA, Martin FC, Michel JP, Sieber C, Stout JR, Studenski SA, Vellas B, Woo J, Zamboni M, Cederholm T. Prevalence of and interventions for sarcopenia in ageing adults: a systematic review. Report of the International Sarcopenia Initiative (EWGSOP and IWGS). Age Ageing. 2014 Nov;43(6):748-59. doi: 10.1093/ageing/afu115. Epub 2014 Sep 21. Review. — View Citation

Drewnowski A, Specter SE. Poverty and obesity: the role of energy density and energy costs. Am J Clin Nutr. 2004 Jan;79(1):6-16. Review. — View Citation

Janssen I, Shepard DS, Katzmarzyk PT, Roubenoff R. The healthcare costs of sarcopenia in the United States. J Am Geriatr Soc. 2004 Jan;52(1):80-5. — View Citation

Lloyd JL, Wellman NS. Older Americans Act Nutrition Programs: A Community-Based Nutrition Program Helping Older Adults Remain at Home. J Nutr Gerontol Geriatr. 2015;34(2):90-109. doi: 10.1080/21551197.2015.1031592. — View Citation

Milne AC, Avenell A, Potter J. Meta-analysis: protein and energy supplementation in older people. Ann Intern Med. 2006 Jan 3;144(1):37-48. Erratum in: Ann Intern Med. 2006 Apr 4;144(7):538. — View Citation

Paddon-Jones D, Rasmussen BB. Dietary protein recommendations and the prevention of sarcopenia. Curr Opin Clin Nutr Metab Care. 2009 Jan;12(1):86-90. doi: 10.1097/MCO.0b013e32831cef8b. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle mass	Dual-energy X-ray absorptimetry	Change from Baseline Muscle Mass at 6 months
Primary	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.	Change from Baseline Physical Function at 6 months
Primary	Muscle Strength	Hand Dynamometer	Change from Baseline Muscle Strength at 6 months
Secondary	Protein intake	24-hour recalls (2 non-consecutive)	Change from Baseline Protein Intake at 6 months
Secondary	Health-Related Quality of Life	Short Form 12 Health Survey	Change from Baseline Health-Related Quality of Life at 6 months
Secondary	Upper Respiratory Illnesses Frequency	Daily illness log	Change From Baseline Upper Respiratory Illness Frequency at 6 months
Secondary	Cognitive Function	Trail Making Test A and B	Change from Baseline Cognitive Function at 6 months
Secondary	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	Change From Baseline Falls Efficacy and Frequency at 6 months
Secondary	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.	Change From Baseline Functional Limitations and Disability at 6 months

External Links

•   Bickel G, Nord M, Price C, Hamilton W, Cook J. Measuring food Security in the United States guide to measuring household food security revised. 2000
•   Borger C, Dys TD, Engelhard E, et al. Hunger in America 2014: Executive summary. 2014
•   Seniors in Bexar County and the City of San Antonio COSA/Bexar County Joint Commission on Elderly Affairs. 2015
•   Strickhouser S, Wright JD, Donley AM. Food insecurity among older adults. AARP Foundation. 2015.
•   Ziliak JP, Gundersen C. The Health Consequences of Senior Hunger in the United States : Evidence from the 1999-2010 NHANES. 2014.