Supplemental Egg Protein Intervention in Older Adults

NCT03530774 | Completed

• 1 other identifier: 17-110
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcopenia; Aging

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Muscle mass

  Dual-energy X-ray absorptimetry

  Change from Baseline Muscle Mass at 6 months

• 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

• Muscle Strength

  Hand Dynamometer

  Change from Baseline Muscle Strength at 6 months

Secondary Outcomes (6)

• Protein intake

  Change from Baseline Protein Intake at 6 months

• Health-Related Quality of Life

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

• Upper Respiratory Illnesses Frequency

  Change From Baseline Upper Respiratory Illness Frequency at 6 months

• Cognitive Function

  Change from Baseline Cognitive Function at 6 months

• Falls Risk

  Change From Baseline Falls Efficacy and Frequency at 6 months

Study Arms (2)

Egg while protein supplement

EXPERIMENTAL

25 g of powdered egg white protein supplement daily for 6 months. Total of 20.6 g of protein in 25 g of supplement.

Dietary Supplement: powdered egg white protein supplement

Maltodextrin supplement

PLACEBO COMPARATOR

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

Dietary Supplement: maltodextrin supplement

Interventions

powdered egg white protein supplement DIETARY_SUPPLEMENT

consumption of egg white protein supplement daily for 6 months

Egg while protein supplement

maltodextrin supplement DIETARY_SUPPLEMENT

consumption of maltodextrin supplement daily for 6 months

Maltodextrin supplement

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older, gait speed \>0.8m/s OR hand grip below 20kg for women or below 30kg for men

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Texas at San Antonio: lead
• Texas State University: collaborator
• American Egg Board: collaborator

Study Sites (1)

University of Texas at San Antonio

San Antonio, Texas, 78249, United States

Location

Related Publications (10)

• 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.

  PMID: 14684391 BACKGROUND

• 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.

  PMID: 20392703 BACKGROUND

• 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.

  PMID: 14687319 BACKGROUND

• 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.

  PMID: 24731978 BACKGROUND

• 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.

  PMID: 25241753 BACKGROUND

• 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.

  PMID: 23827439 BACKGROUND

• 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.

  PMID: 19057193 BACKGROUND

• 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.

  PMID: 26106983 BACKGROUND

• 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.

  PMID: 16389253 BACKGROUND

• 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.

  PMID: 34730461 DERIVED

Related Links

• Ziliak JP, Gundersen C. The Health Consequences of Senior Hunger in the United States : Evidence from the 1999-2010 NHANES. 2014.
• Borger C, Dys TD, Engelhard E, et al. Hunger in America 2014: Executive summary. 2014
• Strickhouser S, Wright JD, Donley AM. Food insecurity among older adults. AARP Foundation. 2015.

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

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

Study Officials

• Sarah L Ullevig, PhD, RD

  University of Texas at San Antonio

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants will be blinded to control (carbohydrate) or egg white protein supplement
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 13, 2017
• First Posted: May 21, 2018
• Study Start: May 31, 2017
• Primary Completion: August 31, 2018
• Study Completion: August 31, 2018
• Last Updated: December 20, 2024

Record last verified: 2020-11

Locations

US (1)