End-Stage Kidney Disease (ESKD)NCT07687498
Effects of Intradialytic Nutrition on Dialysis Adequacy and Fatigue
A study testing Standardized Intradialytic Nutrition in people with End-Stage Kidney Disease (ESKD) and Hemodialysis, run by Mersin University at 2 sites in Turkey (Türkiye).
Trial summary
This randomized, two-period, two-sequence crossover trial aims to evaluate the effects of intradialytic nutrition on dialysis adequacy, intradialytic hemodynamic parameters, and fatigue in adults receiving maintenance hemodialysis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End-Stage Kidney Disease (ESKD), Hemodialysis
- What is being tested?
- Standardized Intradialytic Nutrition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Apr 2022to 30 Jun 2022
- 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
- Adults aged 18 years or older.
- Receiving maintenance hemodialysis three times per week for at least 3 months.
- Clinically stable.
- Able to provide written informed consent.
Who cannot join
- Active infection.
- Hospitalization within the previous month.
- Gastrointestinal disorders affecting oral intake.
- Severe intradialytic hypotension requiring frequent intervention (MAP <65 mmHg).
- Cognitive impairment.
- Pregnancy.
- Scheduled kidney transplantation with an available donor during the study period.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Diamer Private Dialysis Center
Mersin, Yenişehir, 33343
Mersin University, Faculty of Medicine Hospital, Hemodialysis Unit
Mersin, Yenişehir, 33343
About this study
Official title: Effects of Intradialytic Nutrition on Dialysis Adequacy and Fatigue in Hemodialysis Patients: A Randomized Crossover Study
This randomized, two-period, two-sequence crossover trial aims to evaluate the effects of intradialytic nutrition on dialysis adequacy, intradialytic hemodynamic parameters, and fatigue in adults receiving maintenance hemodialysis. Participants will receive standardized intradialytic nutrition during one study period and no food intake during the other period, with each participant serving as their own control. Dialysis adequacy will be assessed using the urea reduction ratio (URR) and single-pool Kt/V (spKt/V), while fatigue will be evaluated using the Piper Fatigue Scale. Intradialytic blood pressure and other clinical parameters will also be monitored throughout the study. The findings are expected to provide evidence regarding the safety and clinical effects of intradialytic nutrition and to support individualized nutritional management strategies for patients undergoing maintenance hemodialysis.
Read the detailed description
Chronic kidney disease is a major global health problem, and maintenance hemodialysis remains the most common renal replacement therapy for patients with end-stage kidney disease. Although hemodialysis prolongs survival, many patients experience treatment-related complications, including intradialytic hypotension, fatigue, and protein-energy wasting, all of which negatively affect quality of life and clinical outcomes.
Adequate nutritional intake is essential for preventing malnutrition in patients receiving maintenance hemodialysis. Because many patients have poor appetite before or after dialysis sessions, intradialytic nutrition has been proposed as an opportunity to improve energy and protein intake. However, the safety and clinical effects of eating during hemodialysis remain controversial. Some studies suggest that food intake during dialysis may reduce dialysis efficiency or contribute to intradialytic hypotension through postprandial hemodynamic changes, whereas other studies have reported no clinically meaningful adverse effects. Consequently, current international recommendations advocate an individualized approach rather than routine intradialytic feeding.
Fatigue is one of the most common and disabling symptoms experienced by patients undergoing maintenance hemodialysis. Although nutritional status has been associated with fatigue, limited evidence is available regarding the direct effect of intradialytic nutrition on fatigue severity. Furthermore, few randomized crossover studies have simultaneously evaluated dialysis adequacy, hemodynamic responses, and patient-reported fatigue outcomes.
This study was designed to provide clinical evidence regarding the effects of standardized intradialytic nutrition on dialysis adequacy, intradialytic hemodynamic stability, and fatigue in adults receiving maintenance hemodialysis. A randomized, two-period, two-sequence crossover design was selected to allow each participant to serve as his or her own control, thereby reducing interindividual variability. The findings are expected to contribute to evidence-based recommendations regarding individualized nutritional practices during hemodialysis and to support clinical decision-making for patients at risk of malnutrition while maintaining treatment safety.
- Conditions
- End-Stage Kidney Disease (ESKD), Hemodialysis
- Being tested
- Standardized Intradialytic Nutrition
- Keywords
- Hemodialysis, Nutrition, Fatigue, Urea, Kinetics
- Medical subject headings
- Kidney Failure, Chronic, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized Intradialytic NutritionDietary supplement
Participants received a standardized renal meal approximately 1.5 hours after the start of each hemodialysis session. The meal provided approximately 450 kcal and 20 g of protein and was designed according to renal dietary recommendations with low potassium and phosphorus content. Participants were instructed to consume the entire meal and not to consume any additional food during the dialysis session.
| Study group | Role | What they receive |
|---|---|---|
| Standardized Intradialytic Nutrition | Experimental | Participants received a standardized renal meal during hemodialysis sessions. Receives: Dietary Supplement: Standardized Intradialytic Nutrition |
| No Intradialytic Food Intake | No intervention | Participants did not consume food during hemodialysis sessions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dialysis Adequacy (spKt/V)
Dialysis adequacy was assessed using single-pool Kt/V (spKt/V)
Measured: At the end of each 4-week study period.
Urea Reduction Ratio (URR)
Urea Reduction Ratio (URR) calculated from routine pre- and post-dialysis blood samples.
Measured: Assessed at the end of each 4-week study period.
Fatigue Severity
Piper Fatigue Scale (22 items; total score 0-220). Higher scores indicate greater fatigue severity (worse fatigue).
Measured: Assessed at the end of each 4-week study period.
Secondary outcomes (2)
Intradialytic Systolic Blood Pressure
Blood pressure was measured before dialysis and hourly during the dialysis session.
Measured: During each dialysis session throughout each 4-week study period.
Intradialytic Diastolic Blood Pressure
Blood pressure was measured before dialysis and hourly during the dialysis session.
Measured: During each dialysis session throughout each 4-week study period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study start1 Apr 2022
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for End-Stage Kidney Disease (ESKD)Studies of the same condition, open and under way.
- More trials run by Mersin 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants were randomized to one of two sequences in a two-period crossover design. Each participant received both interventions (standardized intradialytic nutrition and no intradialytic food intake) in different periods and served as his or her own control. Arm 1 Arm Title: Standardized Intradialytic Nutrition Arm Type: Experimental Description: Participants received a standardized renal meal during hemodialysis sessions. Intervention Type: Dietary Supplement (veya Other) Intervention Name: Standardized Intradialytic Nutrition Arm 2 Arm Title: No Intradialytic Food Intake Arm Type: No Intervention Description: Participants did not consume food during hemodialysis sessions. Intervention: (No Intervention)
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mersin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meral Gun, Mersin University
- Investigators
- Esra Köse, MSc, Principal investigator, Mersin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07687498
- Sponsor's protocol ID
- MEU-MG-HF-01
- Status last verified
- Jul 2026
- First submitted
- 26 Jun 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be made publicly available because the study did not include a data-sharing plan in the informed consent process, and data contain confidential participant information.
Publications
Kose E, Gun M. Effects of intradialytic nutrition on dialysis adequacy and fatigue in hemodialysis patients: a randomized crossover study. Rev Esc Enferm USP. 2026 Sep 11;60:e20260010. doi: 10.1590/1980-220X-REEUSP-2026-0010en. eCollection 2026. English, Spanish.
PubMed 42726135
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Intradialytic Nutrition on Dialysis Adequacy and Fatigue in Hemodialysis Patients: A Randomized Crossover Study
- ClinicalTrials.gov ID
- NCT07687498
- Acronym / sponsor ID
- MEU-MG-HF-01
- Conditions
- End-Stage Kidney Disease (ESKD), Hemodialysis
- Keywords
- Hemodialysis, Nutrition, Fatigue, Urea, Kinetics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Mersin UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 7 Jul 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.
This randomized, two-period, two-sequence crossover trial aims to evaluate the effects of intradialytic nutrition on dialysis adequacy, intradialytic hemodynamic parameters, and fatigue in adults receiving maintenance hemodialysis. Participants will receive standardized intradialytic nutrition during one study period and no food intake during the other period, with each participant serving as their own control. Dialysis adequacy will be assessed using the urea reduction ratio (URR) and single-pool Kt/V (spKt/V), while fatigue will be evaluated using the Piper Fatigue Scale. Intradialytic blood pressure and other clinical parameters will also be monitored throughout the study. The findings are expected to provide evidence regarding the safety and clinical effects of intradialytic nutrition and to support individualized nutritional management strategies for patients undergoing maintenance hemodialysis.
Detailed description
Chronic kidney disease is a major global health problem, and maintenance hemodialysis remains the most common renal replacement therapy for patients with end-stage kidney disease. Although hemodialysis prolongs survival, many patients experience treatment-related complications, including intradialytic hypotension, fatigue, and protein-energy wasting, all of which negatively affect quality of life and clinical outcomes.
Adequate nutritional intake is essential for preventing malnutrition in patients receiving maintenance hemodialysis. Because many patients have poor appetite before or after dialysis sessions, intradialytic nutrition has been proposed as an opportunity to improve energy and protein intake. However, the safety and clinical effects of eating during hemodialysis remain controversial. Some studies suggest that food intake during dialysis may reduce dialysis efficiency or contribute to intradialytic hypotension through postprandial hemodynamic changes, whereas other studies have reported no clinically meaningful adverse effects. Consequently, current international recommendations advocate an individualized approach rather than routine intradialytic feeding.
Fatigue is one of the most common and disabling symptoms experienced by patients undergoing maintenance hemodialysis. Although nutritional status has been associated with fatigue, limited evidence is available regarding the direct effect of intradialytic nutrition on fatigue severity. Furthermore, few randomized crossover studies have simultaneously evaluated dialysis adequacy, hemodynamic responses, and patient-reported fatigue outcomes.
This study was designed to provide clinical evidence regarding the effects of standardized intradialytic nutrition on dialysis adequacy, intradialytic hemodynamic stability, and fatigue in adults receiving maintenance hemodialysis. A randomized, two-period, two-sequence crossover design was selected to allow each participant to serve as his or her own control, thereby reducing interindividual variability. The findings are expected to contribute to evidence-based recommendations regarding individualized nutritional practices during hemodialysis and to support clinical decision-making for patients at risk of malnutrition while maintaining treatment safety.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were randomized to one of two sequences in a two-period crossover design. Each participant received both interventions (standardized intradialytic nutrition and no intradialytic food intake) in different periods and served as his or her own control. Arm 1 Arm Title: Standardized Intradialytic Nutrition Arm Type: Experimental Description: Participants received a standardized renal meal during hemodialysis sessions. Intervention Type: Dietary Supplement (veya Other) Intervention Name: Standardized Intradialytic Nutrition Arm 2 Arm Title: No Intradialytic Food Intake Arm Type: No Intervention Description: Participants did not consume food during hemodialysis sessions. Intervention: (No Intervention)
| Arm | Type | Receives |
|---|---|---|
| Standardized Intradialytic Nutrition | Experimental | Dietary Supplement: Standardized Intradialytic NutritionParticipants received a standardized renal meal during hemodialysis sessions. |
| No Intradialytic Food Intake | No intervention | –Participants did not consume food during hemodialysis sessions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 18 years or older.
- Receiving maintenance hemodialysis three times per week for at least 3 months.
- Clinically stable.
- Able to provide written informed consent.
Key exclusion criteria (7 listed)
- Active infection.
- Hospitalization within the previous month.
- Gastrointestinal disorders affecting oral intake.
- Severe intradialytic hypotension requiring frequent intervention (MAP <65 mmHg).
- Cognitive impairment.
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 |
|---|---|---|
| Standardized Intradialytic NutritionParticipants received a standardized renal meal approximately 1.5 hours after the start of each hemodialysis session. The meal provided approximately 450 kcal and 20 g of protein and was designed according to renal dietary recommendations with low potassium and phosphorus content. Participants were instructed to consume the entire meal and not to consume any additional food during the dialysis session. | Dietary supplement | Standardized Intradialytic Nutrition |
Primary outcome
Dialysis Adequacy (spKt/V)
Time frame: At the end of each 4-week study period.
Dialysis adequacy was assessed using single-pool Kt/V (spKt/V)
Urea Reduction Ratio (URR)
Time frame: Assessed at the end of each 4-week study period.
Urea Reduction Ratio (URR) calculated from routine pre- and post-dialysis blood samples.
Fatigue Severity
Time frame: Assessed at the end of each 4-week study period.
Piper Fatigue Scale (22 items; total score 0-220). Higher scores indicate greater fatigue severity (worse fatigue).
2 secondary outcomes
Intradialytic Systolic Blood Pressure
Time frame: During each dialysis session throughout each 4-week study period.
Intradialytic Diastolic Blood Pressure
Time frame: During each dialysis session throughout each 4-week study period.
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 7 Jul 2026.
- Derived from this study: PubMed 42726135Kose E, Gun M. Effects of intradialytic nutrition on dialysis adequacy and fatigue in hemodialysis patients: a randomized crossover study. Rev Esc Enferm USP. 2026 Sep 11;60:e20260010. doi: 10.1590/1980-220X-REEUSP-2026-0010en. eCollection 2026. English, Spanish.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be made publicly available because the study did not include a data-sharing plan in the informed consent process, and data contain confidential participant information.
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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.
Esra Köse, MSc principal investigator
Mersin University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standardized Intradialytic Nutrition in people with End-Stage Kidney Disease (ESKD) and Hemodialysis, run by Mersin University at 2 sites in Turkey (Türkiye).
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 4 inclusion and 7 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 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). 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?
Dialysis Adequacy (spKt/V) (time frame: At the end of each 4-week study period.). 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 NCT07687498, which also lists 1 linked publication.
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 7 Jul 2026.