Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Texas State University | OTHER |
| American Egg Board | OTHER |
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| powdered egg white protein supplement | Dietary Supplement | consumption of egg white protein supplement daily for 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Protein intake | 24-hour recalls (2 non-consecutive) | Change from Baseline Protein Intake at 6 months |
| Health-Related Quality of Life | Short Form 12 Health Survey |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sarah L Ullevig, PhD, RD | University of Texas at San Antonio | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas at San Antonio | San Antonio | Texas | 78249 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14684391 | Background | 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. | |
| 20392703 | 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. |
| Label | URL |
|---|---|
| Ziliak JP, Gundersen C. The Health Consequences of Senior Hunger in the United States : Evidence from the 1999-2010 NHANES. 2014. | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D055948 | Sarcopenia |
| ID | Term |
|---|---|
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Participants will be blinded to control (carbohydrate) or egg white protein supplement
| maltodextrin supplement | Dietary Supplement | consumption of maltodextrin supplement daily for 6 months |
|
| Change from Baseline Health-Related Quality of Life at 6 months |
| Upper Respiratory Illnesses Frequency | Daily illness log | Change From Baseline Upper Respiratory Illness Frequency at 6 months |
| Cognitive Function | Trail Making Test A and B | Change from Baseline Cognitive Function at 6 months |
| 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 |
| 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 |
| 14687319 | 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. |
| 24731978 | 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. |
| 25241753 | 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. |
| 23827439 | 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. |
| 19057193 | 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. |
| 26106983 | 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. |
| 16389253 | 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. |
| 34730461 | Derived | 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. |
| Borger C, Dys TD, Engelhard E, et al. Hunger in America 2014: Executive summary. 2014 | View source |
| Strickhouser S, Wright JD, Donley AM. Food insecurity among older adults. AARP Foundation. 2015. | View source |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |