SarcopeniaEAF-HDNCT07877545
Egg Albumin and Agave Fructans With Exercise in Hemodialysis
A study testing HemProt and Functional Exercise Program in people with Sarcopenia and Chronic Kidney Disease, run by Centenario Hospital Miguel Hidalgo at 1 site in Mexico.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Sarcopenia, Chronic Kidney Disease, Hemodialysis
- What is being tested?
- HemProt and Functional Exercise Program
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteMexico
- Study dates
- 3 Aug 2026to 3 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 to 80 years.
- Patients with chronic kidney disease receiving maintenance hemodialysis.
- Receiving maintenance hemodialysis.
- Able to perform the prescribed exercise program.
- Able and willing to provide written informed consent.
Who cannot join
- Acute illness or active infection.
- Unstable cardiovascular disease or any medical condition that contraindicates exercise.
- Pregnancy or breastfeeding.
- Participation in another interventional clinical trial.
- Inability to comply with the study procedures or complete follow-up.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Centenario Hospital Miguel Hidalgo
Aguascalientes, Aguascalientes, 20000
About this study
Official title: Effect of Egg Albumin and Agave Fructan Supplementation Combined With Functional Exercise on Muscle Mass, Physical Function, and Inflammatory Status in Patients Receiving Hemodialysis: A Randomized Controlled Trial
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.
Read the detailed description
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.
- Conditions
- Sarcopenia, Chronic Kidney Disease, Hemodialysis
- Being tested
- HemProt, Functional Exercise Program
- Keywords
- Egg albumin, Agave fructans, Exercice, Muscle mass, Physycal function, Inflammation, Handgrip strenght
- Medical subject headings
- Sarcopenia, Renal Insufficiency, Chronic, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HemProtDietary supplement
Participants will receive daily oral supplementation with HemProt, a nutritional supplement containing egg albumin and agave fructans, throughout the study period.
Functional Exercise ProgramBehavioural
Participants will perform a structured functional exercise program during maintenance hemodialysis to improve muscle strength and physical function.
| Study group | Role | What they receive |
|---|---|---|
| Exercise + Egg Albumin + Agave Fructans | Experimental | Participants will receive egg albumin and agave fructan supplementation combined with a structured functional exercise program during maintenance hemodialysis. Receives: Dietary Supplement: HemProt; Behavioral: Functional Exercise Program |
| Egg Albumin + Agave Fructans | Experimental | Participants will receive egg albumin and agave fructan supplementation without the structured functional exercise program. Receives: Dietary Supplement: HemProt |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Baseline and week 16
Secondary outcomes (1)
Change in Inflammatory Status
Change in inflammatory biomarkers measured from baseline to the end of the 16-week intervention.
Measured: Baseline and Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2026
- Study start3 Aug 2026
- Primary completion3 Feb 2027 (estimated)
- Study completion3 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centenario Hospital Miguel Hidalgo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Geovana Martín Alemañy, PHD, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07877545
- Sponsor's protocol ID
- CHMH-HD-2026-2
- Acronym
- EAF-HD
- Status last verified
- Oct 2026
- First submitted
- 7 Oct 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Egg Albumin and Agave Fructan Supplementation Combined With Functional Exercise on Muscle Mass, Physical Function, and Inflammatory Status in Patients Receiving Hemodialysis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07877545
- Acronym / sponsor ID
- EAF-HD / CHMH-HD-2026-2
- Conditions
- Sarcopenia, Chronic Kidney Disease, Hemodialysis
- Keywords
- Egg albumin, Agave fructans, Exercice, Muscle mass, Physycal function, Inflammation, Handgrip strenght
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Centenario Hospital Miguel HidalgoUniversity, hospital or other
- Study start
- 3 Aug 2026 (actual)
- Primary completion
- 3 Feb 2027 (estimated)
- Study completion
- 3 Feb 2027 (estimated)
- First posted
- 16 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise + Egg Albumin + Agave Fructans | Experimental | Dietary Supplement: HemProt, Behavioral: Functional Exercise ProgramParticipants will receive egg albumin and agave fructan supplementation combined with a structured functional exercise program during maintenance hemodialysis. |
| Egg Albumin + Agave Fructans | Experimental | Dietary Supplement: HemProtParticipants will receive egg albumin and agave fructan supplementation without the structured functional exercise program. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 18 to 80 years.
- Patients with chronic kidney disease receiving maintenance hemodialysis.
- Receiving maintenance hemodialysis.
- Able to perform the prescribed exercise program.
- Able and willing to provide written informed consent.
Key exclusion criteria (5 listed)
- Acute illness or active infection.
- Unstable cardiovascular disease or any medical condition that contraindicates exercise.
- Pregnancy or breastfeeding.
- Participation in another interventional clinical trial.
- Inability to comply with the study procedures or complete follow-up.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HemProtParticipants will receive daily oral supplementation with HemProt, a nutritional supplement containing egg albumin and agave fructans, throughout the study period. | Dietary supplement | Egg Albumin + Agave Fructans, Exercise + Egg Albumin + Agave Fructans |
| Functional Exercise ProgramParticipants will perform a structured functional exercise program during maintenance hemodialysis to improve muscle strength and physical function. | Behavioural | Exercise + Egg Albumin + Agave Fructans |
Primary outcome
Change in Short Physical Performance Battery (SPPB) Score
Time frame: Baseline and Week 16
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.
Change in Muscle Mass
Time frame: Baseline and Week 16
Change in muscle mass measured by bioelectrical impedance analysis (BIA) from baseline to the end of the 16-week intervention.
Change in Handgrip Strength
Time frame: Baseline and Week 16
Change in handgrip strength measured in kilograms (kg) using a handgrip dynamometer from baseline to Week 16. Higher values indicate greater muscle strength.
Change in Six-Minute Walk Distance (6MWT)
Time frame: Baseline and week 16
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
1 secondary outcome
Change in Inflammatory Status
Time frame: Baseline and Week 16
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
Related trials for Sarcopenia
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
MF-300 for Treatment of Age-Related Sarcopenia
Sarcopenia in Elderly
Not yet recruitingObservational study
Validation of Uzbek SARC-F and IPAQ-SF Questionnaires in Adults With and Without Hypothyroidism
Hypothyroidism, Psychometrics
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Geovana Martín Alemañy, PHD principal investigator
University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HemProt and Functional Exercise Program in people with Sarcopenia and Chronic Kidney Disease, run by Centenario Hospital Miguel Hidalgo at 1 site in Mexico.
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 5 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 16 Oct 2026. 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 Mexico. 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. 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?
This study is still under way. Results are not available in the source record yet.
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?
Change in Short Physical Performance Battery (SPPB) Score (time frame: Baseline and Week 16). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Oct 2026.