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Supplemental Egg Protein Intervention in Older Adults

NCT ID: NCT03530774

Last Updated: 2024-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-31

Study Completion Date

2018-08-31

Brief Summary

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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

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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.

Conditions

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Sarcopenia Aging

Keywords

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physical performance battery 24-hour dietary recalls dual-energy X-ray absorptimetry dietary supplement protein

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
Participants will be blinded to control (carbohydrate) or egg white protein supplement

Study Groups

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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.

Group Type EXPERIMENTAL

powdered egg white protein supplement

Intervention Type DIETARY_SUPPLEMENT

consumption of egg white protein supplement daily for 6 months

Maltodextrin supplement

25 g of powdered maltodextrin supplement daily for 6 months. Total 23.5 g of carbohydrate in 25 g of supplement.

Group Type PLACEBO_COMPARATOR

maltodextrin supplement

Intervention Type DIETARY_SUPPLEMENT

consumption of maltodextrin supplement daily for 6 months

Interventions

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powdered egg white protein supplement

consumption of egg white protein supplement daily for 6 months

Intervention Type DIETARY_SUPPLEMENT

maltodextrin supplement

consumption of maltodextrin supplement daily for 6 months

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Texas State University

OTHER

Sponsor Role collaborator

American Egg Board

OTHER

Sponsor Role collaborator

The University of Texas at San Antonio

OTHER

Sponsor Role lead

Responsible Party

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Sarah Ullevig

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sarah L Ullevig, PhD, RD

Role: PRINCIPAL_INVESTIGATOR

University of Texas at San Antonio

Locations

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University of Texas at San Antonio

San Antonio, Texas, United States

Site Status

Countries

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United States

References

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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. doi: 10.1093/ajcn/79.1.6.

Reference Type BACKGROUND
PMID: 14684391 (View on PubMed)

Cruz-Jentoft AJ, Baeyens JP, Bauer JM, Boirie Y, Cederholm T, Landi F, Martin FC, Michel JP, Rolland Y, Schneider SM, Topinkova 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.

Reference Type BACKGROUND
PMID: 20392703 (View on PubMed)

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. doi: 10.1111/j.1532-5415.2004.52014.x.

Reference Type BACKGROUND
PMID: 14687319 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24731978 (View on PubMed)

Cruz-Jentoft AJ, Landi F, Schneider SM, Zuniga 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.

Reference Type BACKGROUND
PMID: 25241753 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23827439 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19057193 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26106983 (View on PubMed)

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. doi: 10.7326/0003-4819-144-1-200601030-00008.

Reference Type BACKGROUND
PMID: 16389253 (View on PubMed)

Ullevig SL, Zuniga K, Austin Lobitz C, Santoyo A, Yin Z. Egg protein supplementation improved upper body muscle strength and protein intake in community-dwelling older adult females who attended congregate meal sites or adult learning centers: A pilot randomized controlled trial. Nutr Health. 2022 Dec;28(4):611-620. doi: 10.1177/02601060211051592. Epub 2021 Nov 3.

Reference Type DERIVED
PMID: 34730461 (View on PubMed)

Related Links

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https://www.feedingamerica.org/sites/default/files/research/senior-hunger-research/senior-health-consequences-2014.pdf

Ziliak JP, Gundersen C. The Health Consequences of Senior Hunger in the United States : Evidence from the 1999-2010 NHANES. 2014.

http://help.feedingamerica.org/HungerInAmerica/hunger-in-america-2014-summary.pdf

Borger C, Dys TD, Engelhard E, et al. Hunger in America 2014: Executive summary. 2014

http://www.aarp.org/content/dam/aarp/aarp_foundation/2015-PDFs/AF-Food-Insecurity-2015Update-Final-Report.pdf

Strickhouser S, Wright JD, Donley AM. Food insecurity among older adults. AARP Foundation. 2015.

Other Identifiers

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17-110

Identifier Type: -

Identifier Source: org_study_id