Hemodialysis ComplicationNCT05952570
Impact of Predialytic Oral Protein on Nutritional Status and Quality of Life in HD Patients
A study testing oral protein nutritional supplement (Fresubin protein powder) and routine nutrition regimen in people with Hemodialysis Complication, run by Alexandria University at 1 site in Egypt.
Trial summary
The aim of this work is to study the effects of oral protein-based supplements on nutritional status in hemodialysis patients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodialysis Complication
- What is being tested?
- oral protein nutritional supplement (Fresubin protein powder) and routine nutrition regimen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2023to 1 Jul 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult hemodialysis patients (≥18 years of age).
- Received dialysis for at least 6 months prior to study screening.
- Receive hemodialysis at least 3 times per week .
Who cannot join
- Receiving nutritional supplementation prior to study commencing or within 1 month of commencement in the study .
- Participants with an allergy to any ingredients in the nutritional supplements.
- Persistent hyperkalemia or hyperphosphatemia (defined as the last 3 months).
- Significant edema and fluid overload.
- Hepatic patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Predialytic Oral Protein-based Supplements on Nutritional Status and Quality of Life in Hemodialysis Patients
The aim of this work is to study the effects of oral protein-based supplements on nutritional status in hemodialysis patients
Read the detailed description
Chronic kidney disease (CKD) is a prevalent chronic condition and the incidence of end-stage renal disease (ESRD) is expected to increase over the next few decades. In patients with CKD, especially in those with ESRD and undergoing maintenance dialysis therapy (MDT), a state of metabolic and nutritional derangements, more aptly called protein-energy wasting (PEW), caused by a combination of insufficient intake, uremic toxins, inflammation, and superimposed catabolism, plays a major role among the many risk factors that affect outcomes of CKD .
Oral nutritional supplement (ONS) is a simple and effective way to supplement energy and protein to malnourished patients on the basis of regular diet. Therefore, if the protein of regular diet in dialysis patients are not enough, they should be supplemented with (ONS) when appropriate.
- Conditions
- Hemodialysis Complication
- Being tested
- oral protein nutritional supplement (Fresubin protein powder), routine nutrition regimen
- Keywords
- oral protein, Protein Supplementation, Hemodialysis, quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral protein nutritional supplement (Fresubin protein powder)Dietary supplement
50 patients will receive oral protein nutritional supplement (Fresubin protein powder 25mg/5scoops per hemodialysis session) 1 hour before the start of the session (predialytic) for 3 months
routine nutrition regimenOther
50 patients will receive a routine nutrition regimen for 3 months. (control group)
| Study group | Role | What they receive |
|---|---|---|
| protein supplement | Experimental | 50 patients will receive oral protein nutritional supplement (Fresubin protein powder 25mg/5scoops per hemodialysis session) 1 hour before the start of the session (predialytic) for 3 months Receives: Dietary Supplement: oral protein nutritional supplement (Fresubin protein powder) |
| control | Placebo comparator | 50 patients will receive a routine nutrition regimen for 3 months. (control group) Receives: Other: routine nutrition regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
effect on nutritional status
assessment of nutritional status change at 3 months from baseline using Subjective Global Assessment (SGA)
Measured: 3 months
effect on quality of life
assessment of quality of life change at 3 months from baseline using the kidney disease quality of life 36 (KDQOL-36) short form
Measured: 3 months
Secondary outcomes (4)
effect on BMI
BMI assessment change at 3 months from baseline
Measured: 3 months
mid arm circumference and triceps skin fold
Measurement of mid arm circumference and triceps skin fold change at 3 months from baseline
Measured: 3 months
dialysis adequacy
Estimation of Kt/V change at 3 months from baseline
Measured: 3 months
effect on serum albumin
measurement of serum albumin change at 3 months from baseline
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2023
- Study start1 Aug 2023
- Primary completion15 Jun 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Hemodialysis ComplicationStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- 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
- Model description
- This research is a randomized multi-center clinical trial in which 100 hemodialysis patients will be randomly assigned to one of the study groups using block randomization with a ratio of 1:1. * Group A: 50 patients will receive oral protein nutritional supplement (Fresubin protein powder 25mg/5scoops per hemodialysis session) 1 hour before the start of the session (predialytic) for 3 months. * Group B: 50 patients will receive a routine nutrition regimen for 3 months. (control group)
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Mamdouh Mahmoud Mohamed Elsayed , MD, Alexandria University
- Investigators
- Mohamed Mamdouh Elsayed, MD, Study chair, lecturerAmr El Kazaz, MBBCh, Study chair, residentEman E EL Gohary, MD, Study chair, ProfessorMohamed M Abdel Kader, MD, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05952570
- Sponsor's protocol ID
- oral protein in HD
- Status last verified
- Jul 2024
- First submitted
- 2 Jul 2023
- Last updated
- 9 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kalantar-Zadeh K, Ikizler TA, Block G, Avram MM, Kopple JD. Malnutrition-inflammation complex syndrome in dialysis patients: causes and consequences. Am J Kidney Dis. 2003 Nov;42(5):864-81. doi: 10.1016/j.ajkd.2003.07.016.
PubMed 14582032Carrero JJ, Nakashima A, Qureshi AR, Lindholm B, Heimburger O, Barany P, Stenvinkel P. Protein-energy wasting modifies the association of ghrelin with inflammation, leptin, and mortality in hemodialysis patients. Kidney Int. 2011 Apr;79(7):749-56. doi: 10.1038/ki.2010.487. Epub 2010 Dec 22.
PubMed 21178976Chan M, Kelly J, Batterham M, Tapsell L. Malnutrition (subjective global assessment) scores and serum albumin levels, but not body mass index values, at initiation of dialysis are independent predictors of mortality: a 10-year clinical cohort study. J Ren Nutr. 2012 Nov;22(6):547-57. doi: 10.1053/j.jrn.2011.11.002. Epub 2012 Mar 9.
PubMed 22406122Ho LC, Wang HH, Peng YS, Chiang CK, Huang JW, Hung KY, Hu FC, Wu KD. Clinical utility of malnutrition-inflammation score in maintenance hemodialysis patients: focus on identifying the best cut-off point. Am J Nephrol. 2008;28(5):840-6. doi: 10.1159/000137684. Epub 2008 Jun 6.
PubMed 18535370Forquet F, Calin V, Trescol-Biemont MC, Kanellopoulos J, Mottez E, Kourilsky P, Rabourdin-Combe C, Gerlier D. Generation of hen egg lysozyme-specific and major histocompatibility complex class I-restricted cytolytic T lymphocytes: recognition of cytosolic and secreted antigen expressed by transfected cells. Eur J Immunol. 1990 Oct;20(10):2325-32. doi: 10.1002/eji.1830201023.
PubMed 2242761Elsayed MM, Abdelkader MM, ElKazaz AM, Elgohary IE. The impact of predialytic oral protein-based supplements on nutritional status and quality of life in hemodialysis patients: a randomized clinical trial. BMC Nephrol. 2025 Feb 26;26(1):103. doi: 10.1186/s12882-025-03999-3.
PubMed 40011815
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Predialytic Oral Protein-based Supplements on Nutritional Status and Quality of Life in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT05952570
- Acronym / sponsor ID
- oral protein in HD
- Conditions
- Hemodialysis Complication
- Keywords
- oral protein, Protein Supplementation, Hemodialysis, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 15 Jun 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 19 Jul 2023 (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.
The aim of this work is to study the effects of oral protein-based supplements on nutritional status in hemodialysis patients
Detailed description
Chronic kidney disease (CKD) is a prevalent chronic condition and the incidence of end-stage renal disease (ESRD) is expected to increase over the next few decades. In patients with CKD, especially in those with ESRD and undergoing maintenance dialysis therapy (MDT), a state of metabolic and nutritional derangements, more aptly called protein-energy wasting (PEW), caused by a combination of insufficient intake, uremic toxins, inflammation, and superimposed catabolism, plays a major role among the many risk factors that affect outcomes of CKD .
Oral nutritional supplement (ONS) is a simple and effective way to supplement energy and protein to malnourished patients on the basis of regular diet. Therefore, if the protein of regular diet in dialysis patients are not enough, they should be supplemented with (ONS) when appropriate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This research is a randomized multi-center clinical trial in which 100 hemodialysis patients will be randomly assigned to one of the study groups using block randomization with a ratio of 1:1. * Group A: 50 patients will receive oral protein nutritional supplement (Fresubin protein powder 25mg/5scoops per hemodialysis session) 1 hour before the start of the session (predialytic) for 3 months. * Group B: 50 patients will receive a routine nutrition regimen for 3 months. (control group)
| Arm | Type | Receives |
|---|---|---|
| protein supplement | Experimental | Dietary Supplement: oral protein nutritional supplement (Fresubin protein powder)50 patients will receive oral protein nutritional supplement (Fresubin protein powder 25mg/5scoops per hemodialysis session) 1 hour before the start of the session (predialytic) for 3 months |
| control | Placebo comparator | Other: routine nutrition regimen50 patients will receive a routine nutrition regimen for 3 months. (control group) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult hemodialysis patients (≥18 years of age).
- Received dialysis for at least 6 months prior to study screening.
- Receive hemodialysis at least 3 times per week .
Key exclusion criteria (5 listed)
- Receiving nutritional supplementation prior to study commencing or within 1 month of commencement in the study .
- Participants with an allergy to any ingredients in the nutritional supplements.
- Persistent hyperkalemia or hyperphosphatemia (defined as the last 3 months).
- Significant edema and fluid overload.
- Hepatic patients
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 |
|---|---|---|
| oral protein nutritional supplement (Fresubin protein powder)50 patients will receive oral protein nutritional supplement (Fresubin protein powder 25mg/5scoops per hemodialysis session) 1 hour before the start of the session (predialytic) for 3 months | Dietary supplement | protein supplement |
| routine nutrition regimen50 patients will receive a routine nutrition regimen for 3 months. (control group) | Other | control |
Primary outcome
effect on nutritional status
Time frame: 3 months
assessment of nutritional status change at 3 months from baseline using Subjective Global Assessment (SGA)
effect on quality of life
Time frame: 3 months
assessment of quality of life change at 3 months from baseline using the kidney disease quality of life 36 (KDQOL-36) short form
4 secondary outcomes
effect on BMI
Time frame: 3 months
mid arm circumference and triceps skin fold
Time frame: 3 months
dialysis adequacy
Time frame: 3 months
effect on serum albumin
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2024.
- Background: PubMed 14582032Kalantar-Zadeh K, Ikizler TA, Block G, Avram MM, Kopple JD. Malnutrition-inflammation complex syndrome in dialysis patients: causes and consequences. Am J Kidney Dis. 2003 Nov;42(5):864-81. doi: 10.1016/j.ajkd.2003.07.016.
- Background: PubMed 21178976Carrero JJ, Nakashima A, Qureshi AR, Lindholm B, Heimburger O, Barany P, Stenvinkel P. Protein-energy wasting modifies the association of ghrelin with inflammation, leptin, and mortality in hemodialysis patients. Kidney Int. 2011 Apr;79(7):749-56. doi: 10.1038/ki.2010.487. Epub 2010 Dec 22.
- Background: PubMed 22406122Chan M, Kelly J, Batterham M, Tapsell L. Malnutrition (subjective global assessment) scores and serum albumin levels, but not body mass index values, at initiation of dialysis are independent predictors of mortality: a 10-year clinical cohort study. J Ren Nutr. 2012 Nov;22(6):547-57. doi: 10.1053/j.jrn.2011.11.002. Epub 2012 Mar 9.
- Background: PubMed 18535370Ho LC, Wang HH, Peng YS, Chiang CK, Huang JW, Hung KY, Hu FC, Wu KD. Clinical utility of malnutrition-inflammation score in maintenance hemodialysis patients: focus on identifying the best cut-off point. Am J Nephrol. 2008;28(5):840-6. doi: 10.1159/000137684. Epub 2008 Jun 6.
- Background: PubMed 2242761Forquet F, Calin V, Trescol-Biemont MC, Kanellopoulos J, Mottez E, Kourilsky P, Rabourdin-Combe C, Gerlier D. Generation of hen egg lysozyme-specific and major histocompatibility complex class I-restricted cytolytic T lymphocytes: recognition of cytosolic and secreted antigen expressed by transfected cells. Eur J Immunol. 1990 Oct;20(10):2325-32. doi: 10.1002/eji.1830201023.
- Derived from this study: PubMed 40011815Elsayed MM, Abdelkader MM, ElKazaz AM, Elgohary IE. The impact of predialytic oral protein-based supplements on nutritional status and quality of life in hemodialysis patients: a randomized clinical trial. BMC Nephrol. 2025 Feb 26;26(1):103. doi: 10.1186/s12882-025-03999-3.
- Individual participant dataSharing planned: Undecided
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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.
Mohamed Mamdouh Elsayed, MD study chair
lecturer
Amr El Kazaz, MBBCh study chair
resident
Eman E EL Gohary, MD study chair
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oral protein nutritional supplement (Fresubin protein powder) and routine nutrition regimen in people with Hemodialysis Complication, run by Alexandria University at 1 site in Egypt.
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 3 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: finished, as of the sponsor's last update on 9 Jul 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 Egypt. 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?
effect on nutritional status (time frame: 3 months). The study lists 2 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 NCT05952570, which also lists 6 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 9 Jul 2024.