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SarcopeniaSPRINCT03530774

Supplemental Egg Protein Intervention in Older Adults

A study testing powdered egg white protein supplement and maltodextrin supplement in people with Sarcopenia and Aging, run by The University of Texas at San Antonio at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Sarcopenia, Aging
What is being tested?
powdered egg white protein supplement and maltodextrin supplement
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
54 participants
Where
1 siteUnited States
Study dates
31 May 2017to 31 Aug 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Texas at San Antonio

    San Antonio, Texas, 78249

Other trials in United States

About this study

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

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.

Read the 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.

Conditions
Sarcopenia, Aging
Being tested
powdered egg white protein supplement, maltodextrin supplement
Keywords
physical performance battery, 24-hour dietary recalls, dual-energy X-ray absorptimetry, dietary supplement, protein
Medical subject headings
Sarcopenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • powdered egg white protein supplementDietary supplement

    consumption of egg white protein supplement daily for 6 months

  • maltodextrin supplementDietary supplement

    consumption of maltodextrin supplement daily for 6 months

Study groups in NCT03530774
Study groupRoleWhat they receive
Egg while protein supplementExperimental25 g of powdered egg white protein supplement daily for 6 months. Total of 20.6 g of protein in 25 g of supplement.
Receives: Dietary Supplement: powdered egg white protein supplement
Maltodextrin supplementPlacebo comparator25 g of powdered maltodextrin supplement daily for 6 months. Total 23.5 g of carbohydrate in 25 g of supplement.
Receives: Dietary Supplement: maltodextrin supplement

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Muscle mass

    Dual-energy X-ray absorptimetry

    Measured: Change from Baseline Muscle Mass at 6 months

  2. 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.

    Measured: Change from Baseline Physical Function at 6 months

  3. Muscle Strength

    Hand Dynamometer

    Measured: Change from Baseline Muscle Strength at 6 months

Secondary outcomes (6)

  1. Protein intake

    24-hour recalls (2 non-consecutive)

    Measured: Change from Baseline Protein Intake at 6 months

  2. Health-Related Quality of Life

    Short Form 12 Health Survey

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

  3. Upper Respiratory Illnesses Frequency

    Daily illness log

    Measured: Change From Baseline Upper Respiratory Illness Frequency at 6 months

  4. Cognitive Function

    Trail Making Test A and B

    Measured: Change from Baseline Cognitive Function at 6 months

  5. 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

    Measured: Change From Baseline Falls Efficacy and Frequency at 6 months

  6. 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.

    Measured: Change From Baseline Functional Limitations and Disability at 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 May 2018
  2. Study start31 May 2017
  3. Primary completion31 Aug 2018
  4. Study completion31 Aug 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03530774
Sponsor's protocol ID
17-110
Acronym
SPRI
Status last verified
Nov 2020
First submitted
13 Oct 2017
Last updated
20 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 14684391

  • 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.

    PubMed 20392703

  • 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.

    PubMed 14687319

  • 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.

    PubMed 24731978

  • 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.

    PubMed 25241753

  • 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.

    PubMed 23827439

  • 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.

    PubMed 19057193

  • 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.

    PubMed 26106983

  • 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.

    PubMed 16389253

  • 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.

    PubMed 34730461

Questions about this trial

What is this clinical trial studying?

A study testing powdered egg white protein supplement and maltodextrin supplement in people with Sarcopenia and Aging, run by The University of Texas at San Antonio at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Muscle mass (time frame: Change from Baseline Muscle Mass at 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03530774, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2024.

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