An interventional study of HemProt and Functional Exercise Program in Sarcopenia, Chronic Kidney Disease and Hemodialysis, sponsored by Centenario Hospital Miguel Hidalgo. Active, not recruiting at 1 site in Mexico. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by Centenario Hospital Miguel Hidalgo · Not applicable, Interventional, and Treatment
Patients receiving maintenance hemodialysis frequently develop loss of muscle mass, reduced physical function, and chronic inflammation. This randomized controlled trial will evaluate whether oral supplementation with egg albumin and agave fructans combined with a structured functional exercise program improves muscle mass, physical function, muscle strength, inflammatory status, phase angle, and quality of life compared with nutritional supplementation alone. A total of 66 adult participants receiving maintenance hemodialysis at Centenario Hospital Miguel Hidalgo will be randomly assigned to one of the two intervention groups and followed for 6 months.
Protein-energy wasting, sarcopenia, chronic inflammation, and reduced physical function are common complications among patients receiving maintenance hemodialysis and are associated with increased morbidity and mortality. Oral nutritional supplementation with high-biological-value protein may improve nutritional status, while prebiotic supplementation may beneficially modulate the gut microbiota and inflammatory response. Exercise has also been shown to improve muscle strength and physical performance.
This randomized controlled trial will evaluate the effect of oral supplementation with egg albumin and agave fructans, combined with a structured functional exercise program, compared with oral supplementation alone in adults receiving maintenance hemodialysis. Participants will be followed for 6 months. Outcomes will include changes in muscle mass measured by bioelectrical impedance analysis, physical function, handgrip strength, phase angle, inflammatory markers, serum albumin, and health-related quality of life.
1,240 studies on the registry are indexed under Sarcopenia; 405 are open to participants now.
This study's planned enrollment of 66 is close to the median of 60 across 793 interventional studies indexed under Sarcopenia.
Browse Sarcopenia studies →Centenario Hospital Miguel Hidalgo is the lead sponsor of 7 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Participants will receive egg albumin and agave fructan supplementation combined with a structured functional exercise program during maintenance hemodialysis.
Dietary Supplement: HemProt · Behavioral: Functional Exercise Program
Participants will receive egg albumin and agave fructan supplementation without the structured functional exercise program.
Dietary Supplement: HemProt
Participants will receive daily oral supplementation with HemProt, a nutritional supplement containing egg albumin and agave fructans, throughout the study period.
Participants will perform a structured functional exercise program during maintenance hemodialysis to improve muscle strength and physical function.
Change in Short Physical Performance Battery (SPPB) Score
Change in physical performance assessed using the Short Physical Performance Battery (SPPB) from baseline to Week 16. The SPPB evaluates balance, gait speed, and lower extremity strength through three standardized tests. The total score ranges from 0 to 12 points, with higher scores indicating better physical performance.
Time frame: Baseline and Week 16
Change in Muscle Mass
Change in muscle mass measured by bioelectrical impedance analysis (BIA) from baseline to the end of the 16-week intervention.
Time frame: Baseline and Week 16
Change in Handgrip Strength
Change in handgrip strength measured in kilograms (kg) using a handgrip dynamometer from baseline to Week 16. Higher values indicate greater muscle strength.
Time frame: Baseline and Week 16
Change in Six-Minute Walk Distance (6MWT)
Change in functional exercise capacity assessed using the Six-Minute Walk Test (6MWT). The total distance walked in six minutes will be measured in meters (m) at baseline and Week 16. Greater distances indicate better functional exercise capacity
Time frame: Baseline and week 16
Change in Inflammatory Status
Change in inflammatory biomarkers measured from baseline to the end of the 16-week intervention.
Time frame: Baseline and Week 16
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Centenario Hospital Miguel Hidalgo