Protein SupplementationNCT05953636
Effect of Different Timings of Protein Supplementation in Hemodialysis Patients
A study testing oral protein nutritional supplement (ONS) (Fresubin protein powder 25mg/5scoops per hemodialysis session) in people with Protein Supplementation, run by Alexandria University at 1 site in Egypt.
Trial summary
The aim of this work is to study the effect of different timings of protein supplementation on variable outcomes in hemodialysis patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Protein Supplementation
- What is being tested?
- oral protein nutritional supplement (ONS) (Fresubin protein powder 25mg/5scoops per hemodialysis session)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2023to 1 May 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.
- Significant edema and fluid overload.
- Hepatic patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Different Timings of Protein Supplementation on Variable Outcomes in Hemodialysis Patients
The aim of this work is to study the effect of different timings of protein supplementation on variable outcomes 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. PEW, showing a high prevalence (up to 50-75%) in patients with CKD stages 4-5, is closely associated with both increased morbidity/mortality risk and worsens quality of life.
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.
It is common for nephrologists to prescribe oral nutritional supplements (ONS), but the compliance to these at prescribed doses is relatively low. While directly administering ONS during hemodialysis (HD) ensures compliance and has been shown to improve nutritional status in these patients, the risks of intradialytic hypotension, inadequate dialysis, hygiene issues, and staff burden remain major deterrents for caregivers from formulating policies with regard to intradialytic meals.
- Conditions
- Protein Supplementation
- Being tested
- oral protein nutritional supplement (ONS) (Fresubin protein powder 25mg/5scoops per hemodialysis session)
- Keywords
- Timing, Protein Supplementation, hemodialysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral protein nutritional supplement (ONS) (Fresubin protein powder 25mg/5scoops per hemodialysis session)Dietary supplement
oral protein nutritional supplement (ONS) (Fresubin protein powder 25mg/5scoops per hemodialysis session) given in group A (predialytic: 1 hour before the start of the session), in group B (intradialytic: 2 hours after the start of the session ), in group C (interdialytic: in non-dialysis days )
| Study group | Role | What they receive |
|---|---|---|
| pre-dialytic | Other | 40 patients will receive oral protein nutritional supplement (ONS) (Fresubin protein powder 25mg/5scoops per hemodialysis session) for 8 weeks 1 hour before the start of the session (pre-dialytic). Receives: Dietary Supplement: oral protein nutritional supplement (ONS) (Fresubin protein powder 25mg/5scoops per hemodialysis session) |
| intra-dialytic | Other | 40 patients will receive oral protein nutritional supplement (ONS) for 8 weeks 2 hours after the start of the session (intra-dialytic). Receives: Dietary Supplement: oral protein nutritional supplement (ONS) (Fresubin protein powder 25mg/5scoops per hemodialysis session) |
| inter-dialytic | Other | 40 patients will receive oral protein nutritional supplement (ONS) for 8 weeks in non-dialysis days (inter-dialytic). Receives: Dietary Supplement: oral protein nutritional supplement (ONS) (Fresubin protein powder 25mg/5scoops per hemodialysis session) |
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 6 weeks from baseline using Subjective Global Assessment (SGA)
Measured: 6 weeks
effect on blood pressure
systolic and diastolic Blood pressure change at 6 weeks from baseline
Measured: 6 weeks
effect on dialysis adequacy
Estimation of Kt/V change at 6 weeks from baseline
Measured: 6 weeks
Secondary outcomes (2)
effect on BMI
BMI assessment change at 6 weeks from baseline
Measured: 6 weeks
effect on serum albumin
- serum albumin change at 6 weeks from baseline
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2023
- Study start1 Nov 2023
- Primary completion1 Apr 2024
- Study completion1 May 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 Protein SupplementationStudies 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 120 hemodialysis patients will be randomly assigned to one of the study groups. * Group A: 40 patients will receive oral protein nutritional supplement (ONS) (Fresubin protein powder 25mg/5scoops per hemodialysis session) for 8 weeks 1 hour before the start of the session (pre-dialytic). * Group B: 40 patients will receive oral protein nutritional supplement (ONS) for 8 weeks 2 hours after the start of the session (intra-dialytic). * Group C: 40 patients will receive oral protein nutritional supplement (ONS) for 8 weeks in non-dialysis days (inter-dialytic).
- Masking
- None (open label)
- Enrolment
- 120 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, Principal investigator, lecturerAmr Mohamed El Kazaz, MBBCh, Study chair, resident
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05953636
- Sponsor's protocol ID
- Timing of protein in HD
- Status last verified
- Jun 2024
- First submitted
- 1 Jul 2023
- Last updated
- 1 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 21178976Ikizler TA, Cano NJ, Franch H, Fouque D, Himmelfarb J, Kalantar-Zadeh K, Kuhlmann MK, Stenvinkel P, TerWee P, Teta D, Wang AY, Wanner C; International Society of Renal Nutrition and Metabolism. Prevention and treatment of protein energy wasting in chronic kidney disease patients: a consensus statement by the International Society of Renal Nutrition and Metabolism. Kidney Int. 2013 Dec;84(6):1096-107. doi: 10.1038/ki.2013.147. Epub 2013 May 22.
PubMed 23698226Agarwal R, Georgianos P. Feeding during dialysis-risks and uncertainties. Nephrol Dial Transplant. 2018 Jun 1;33(6):917-922. doi: 10.1093/ndt/gfx195.
PubMed 28633456Kistler BM, Benner D, Burrowes JD, Campbell KL, Fouque D, Garibotto G, Kopple JD, Kovesdy CP, Rhee CM, Steiber A, Stenvinkel P, Ter Wee P, Teta D, Wang AYM, Kalantar-Zadeh K. Eating During Hemodialysis Treatment: A Consensus Statement From the International Society of Renal Nutrition and Metabolism. J Ren Nutr. 2018 Jan;28(1):4-12. doi: 10.1053/j.jrn.2017.10.003.
PubMed 29249295Elsayed MM, Elkazaz AM. The effect of different timings of protein supplementation on variable outcomes in hemodialysis patients: a randomized clinical trial. Clin Exp Nephrol. 2025 May;29(5):672-680. doi: 10.1007/s10157-025-02626-7. Epub 2025 Jan 18.
PubMed 39826005
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Different Timings of Protein Supplementation on Variable Outcomes in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT05953636
- Acronym / sponsor ID
- Timing of protein in HD
- Conditions
- Protein Supplementation
- Keywords
- Timing, Protein Supplementation, hemodialysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 20 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 effect of different timings of protein supplementation on variable outcomes 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. PEW, showing a high prevalence (up to 50-75%) in patients with CKD stages 4-5, is closely associated with both increased morbidity/mortality risk and worsens quality of life.
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.
It is common for nephrologists to prescribe oral nutritional supplements (ONS), but the compliance to these at prescribed doses is relatively low. While directly administering ONS during hemodialysis (HD) ensures compliance and has been shown to improve nutritional status in these patients, the risks of intradialytic hypotension, inadequate dialysis, hygiene issues, and staff burden remain major deterrents for caregivers from formulating policies with regard to intradialytic meals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This research is a randomized multi-center clinical trial in which 120 hemodialysis patients will be randomly assigned to one of the study groups. * Group A: 40 patients will receive oral protein nutritional supplement (ONS) (Fresubin protein powder 25mg/5scoops per hemodialysis session) for 8 weeks 1 hour before the start of the session (pre-dialytic). * Group B: 40 patients will receive oral protein nutritional supplement (ONS) for 8 weeks 2 hours after the start of the session (intra-dialytic). * Group C: 40 patients will receive oral protein nutritional supplement (ONS) for 8 weeks in non-dialysis days (inter-dialytic).
| Arm | Type | Receives |
|---|---|---|
| pre-dialytic | Other | Dietary Supplement: oral protein nutritional supplement (ONS) (Fresubin protein powder 25mg/5scoops per hemodialysis session)40 patients will receive oral protein nutritional supplement (ONS) (Fresubin protein powder 25mg/5scoops per hemodialysis session) for 8 weeks 1 hour before the start of the session (pre-dialytic). |
| intra-dialytic | Other | Dietary Supplement: oral protein nutritional supplement (ONS) (Fresubin protein powder 25mg/5scoops per hemodialysis session)40 patients will receive oral protein nutritional supplement (ONS) for 8 weeks 2 hours after the start of the session (intra-dialytic). |
| inter-dialytic | Other | Dietary Supplement: oral protein nutritional supplement (ONS) (Fresubin protein powder 25mg/5scoops per hemodialysis session)40 patients will receive oral protein nutritional supplement (ONS) for 8 weeks in non-dialysis days (inter-dialytic). |
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 (4 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.
- 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 (ONS) (Fresubin protein powder 25mg/5scoops per hemodialysis session)oral protein nutritional supplement (ONS) (Fresubin protein powder 25mg/5scoops per hemodialysis session) given in group A (predialytic: 1 hour before the start of the session), in group B (intradialytic: 2 hours after the start of the session ), in group C (interdialytic: in non-dialysis days ) | Dietary supplement | inter-dialytic, intra-dialytic, pre-dialytic |
Primary outcome
effect on nutritional status
Time frame: 6 weeks
assessment of nutritional status change at 6 weeks from baseline using Subjective Global Assessment (SGA)
effect on blood pressure
Time frame: 6 weeks
systolic and diastolic Blood pressure change at 6 weeks from baseline
effect on dialysis adequacy
Time frame: 6 weeks
Estimation of Kt/V change at 6 weeks from baseline
2 secondary outcomes
effect on BMI
Time frame: 6 weeks
effect on serum albumin
Time frame: 6 weeks
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 1 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 23698226Ikizler TA, Cano NJ, Franch H, Fouque D, Himmelfarb J, Kalantar-Zadeh K, Kuhlmann MK, Stenvinkel P, TerWee P, Teta D, Wang AY, Wanner C; International Society of Renal Nutrition and Metabolism. Prevention and treatment of protein energy wasting in chronic kidney disease patients: a consensus statement by the International Society of Renal Nutrition and Metabolism. Kidney Int. 2013 Dec;84(6):1096-107. doi: 10.1038/ki.2013.147. Epub 2013 May 22.
- Background: PubMed 28633456Agarwal R, Georgianos P. Feeding during dialysis-risks and uncertainties. Nephrol Dial Transplant. 2018 Jun 1;33(6):917-922. doi: 10.1093/ndt/gfx195.
- Background: PubMed 29249295Kistler BM, Benner D, Burrowes JD, Campbell KL, Fouque D, Garibotto G, Kopple JD, Kovesdy CP, Rhee CM, Steiber A, Stenvinkel P, Ter Wee P, Teta D, Wang AYM, Kalantar-Zadeh K. Eating During Hemodialysis Treatment: A Consensus Statement From the International Society of Renal Nutrition and Metabolism. J Ren Nutr. 2018 Jan;28(1):4-12. doi: 10.1053/j.jrn.2017.10.003.
- Derived from this study: PubMed 39826005Elsayed MM, Elkazaz AM. The effect of different timings of protein supplementation on variable outcomes in hemodialysis patients: a randomized clinical trial. Clin Exp Nephrol. 2025 May;29(5):672-680. doi: 10.1007/s10157-025-02626-7. Epub 2025 Jan 18.
- Individual participant dataSharing planned: Undecided
Related trials for Protein Supplementation
Not yet recruiting
Dietary Supplementation and Hydration
Hydration
Recruiting
Effects of Dietary Supplements on Muscle Mass and Function While Using GLP-1 Medication
Obesity & Overweight, Muscle Mass and Strength
Recruiting
PROtein, Leucine and Vitamin D Supplementation In Patients With GYnecologic Cancer Receiving Platinum-based Chemotherapy
Gynecologic Cancer
Recruiting
Fueling Labor: Protein Supplementation for Intrapartum Glucose Control
Diabetes During Pregnancy
Recruiting
IgG Binding Protein LT in Support of a Healthy Gut on the Go
Gut Health, Gastrointestinal Symptoms
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 principal investigator
lecturer
Amr Mohamed El Kazaz, MBBCh study chair
resident
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 (ONS) (Fresubin protein powder 25mg/5scoops per hemodialysis session) in people with Protein Supplementation, 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 4 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 1 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. 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: 6 weeks). 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 NCT05953636, 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 1 Jul 2024.