End Stage Renal DiseaseNCT03947710
Effect of Protein Intake During Hemodialysis on Blood Pressure and Arterial Stiffness Indices
A study testing High-protein meals, Low- protein meals and No meals in people with End Stage Renal Disease and Hypotension During Dialysis, run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial summary
Open label, randomized, cross-over clinical study comparing the acute effect of high versus low protein meals during dialysis on intradialytic blood pressure, 24-hour ambulatory blood pressure and arterial stiffness indices on maintenance hemodialysis patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- End Stage Renal Disease, Hypotension During Dialysis, Protein Malnutrition
- What is being tested?
- High-protein meals, Low- protein meals and No meals
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteGreece
- Study dates
- 1 Aug 2019to 1 Aug 2020
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients to have provided informed written consent
- Patients undergoing maintenance hemodialysis for at least 3 months prior to enrollment
- Ability to self-ingest food during the dialysis session
Who cannot join
- History of malignancy or any other clinical condition associated with very poor prognosis
- Hospitalization for acute myocardial infarction, unstable angina or acute ischemic stroke within the 3 previous months
- Patients receiving parenteral nutrition
- Body mass index (BMI) of >40 kg/m2
- Bilateral functioning or non-functioning arteriovenous fistula (AVF) and/or arteriovenous graft (AVG) used as dialysis access
- Patients with major amputations (eg lower limbs)
- Women during pregnancy or lactation
- Patients with unsuccessful 24-hour ambulatory recording of blood pressure with Mobil-O-Graph device, in accordance with the current European Society of Hypertension Guidelines.
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
AHEPA University Hospital
Thessaloniki, Select A State/Province, 54636
Vassilios Liakopoulos, 6932293544, liakopul@otenet.gr
About this study
Official title: Acute Effect of Protein Intake During Dialysis on Intradialytic Blood Pressure, 24-hour Ambulatory Blood Pressure and Arterial Stiffness Indices in Maintenance Hemodialysis Patients.
Open label, randomized, cross-over clinical study comparing the acute effect of high versus low protein meals during dialysis on intradialytic blood pressure, 24-hour ambulatory blood pressure and arterial stiffness indices on maintenance hemodialysis patients.
Read the detailed description
A series of demographic, anthropometric and clinical data will be collected prior to enrollment. The intervention will last 3 consecutive weeks. Eligible subjects will be randomised to one group (high or low protein meals during dialysis) for one week (3 dialysis sessions). Second week will be a wash out period (patients will not consume meals during dialysis) and during the third week randomised subjects will cross over to the other study group. Every meal will provide 1/3 of daily recommended energy and protein intake (35 kcal/kg body weight/day, 0.7 gr protein/kg body weight/day for low protein meals and 1.5 gr protein/kg body weight/day for high protein meals). All the meals will be prepared in the hospital's kitchen and will be personalized to each patient's preferences. The meal will be given one hour after the start of the session and should be consumed completely during dialysis.
Patients will be evaluated for the following parameters during their midweek dialysis session:
- Intradialytic blood pressure
- 24-hour ambulatory blood pressure
- Arterial stiffness indices (Central Aortic blood pressure, Pulse Wave Velocity, Augmentation Index)
- Hemodialysis adequacy
- Nutritional status
Intradialytic blood pressure, 24-hour ambulatory blood pressure and arterial stiffness indices will be evaluated with the use of the brachial cuff-based oscillometric device Mobil-O-Graph NG (IEM, Stolberg, Germany). Urea reduction ratio (URR) and Kt/V (standard and equilibrated) will be used as measures for dialysis adequacy. Possible changes in patients nutritional status will be assessed using the Malnutrition-Inflammation Score (MIS).
- Conditions
- End Stage Renal Disease, Hypotension During Dialysis, Protein Malnutrition, Arterial Sclerosis
- Being tested
- High-protein meals, Low- protein meals, No meals
- Medical subject headings
- Kidney Failure, Chronic, Kwashiorkor, Arteriosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-protein mealsOther
Patients on maintenance hemodialysis will consume high protein meals during dialysis for one week (3 dialysis sessions)
Low- protein mealsOther
Patients on maintenance hemodialysis will consume low protein meals during dialysis for one week (3 dialysis sessions)
No mealsOther
Patients on maintenance hemodialysis will not consume meals during dialysis for one week (3 dialysis sessions)
| Study group | Role | What they receive |
|---|---|---|
| High-protein meals | Experimental | Patients with End Stage Renal disease on maintenance hemodialysis will consume high protein meals during their dialysis sessions for one week. Receives: Other: High-protein meals |
| Low-protein meals | Experimental | Patients with End Stage Renal disease on maintenance hemodialysis will consume low protein meals during their dialysis sessions for one week Receives: Other: Low- protein meals |
| No meals | Experimental | Patients with End Stage Renal disease on maintenance hemodialysis will not consume meals during their dialysis sessions for one week Receives: Other: No meals |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of meal versus no meal consumption during hemodialysis on intradialytic blood pressure
Meal consumption is expected to lower intradialytic blood pressure and increase hypotensive events during hemodialysis. Intradialytic blood pressure will be evaluated with the use of the brachial cuff-based oscillometric device Mobil-O-Graph NG (IEM, Stolberg, Germany) during the midweek dialysis session.
Measured: 3 weeks
Effect of high versus low protein meal consumption during dialysis on intradialytic blood pressure
High protein meals are expected to affect less intradialytic blood pressure than low protein meals. Intradialytic blood pressure will be evaluated with the use of the brachial cuff-based oscillometric device Mobil-O-Graph NG (IEM, Stolberg, Germany) during the midweek dialysis session.
Measured: 3 weeks
Secondary outcomes (5)
Effect of high versus low protein meal consumption during dialysis on 24-hour ambulatory blood pressure
24-hour blood pressure will be evaluated with the use of the brachial cuff-based oscillometric device Mobil-O-Graph NG (IEM, Stolberg, Germany). Measurement of 24-hour ambulatory blood pressure will start at the beginning of the midweek dialysis session for each group (high versus low protein meals during dialysis).
Measured: 3 weeks
Effect of high versus low protein meal consumption during dialysis on Pulse Wave Velocity
Pulse Wave Velocity will be measured for each group (high versus low protein meals) during the midweek dialysis session using the brachial cuff-based oscillometric device Mobil-O-Graph NG (IEM, Stolberg, Germany).
Measured: 3 weeks
Effect of high versus low protein meal consumption during dialysis on Augmentation Index
Augmentation Index will be measured for each group (high versus low protein meals) during the midweek dialysis session using the brachial cuff-based oscillometric device Mobil-O-Graph NG (IEM, Stolberg, Germany).
Measured: 3 weeks
Effect of high versus low protein meals during dialysis on hemodialysis adequacy.
Hemodialysis adequacy will be calculated for each patient group (high versus low protein meals) using the Urea reduction ratio (URR) and Kt/V (standard and equilibrated) for the midweek dialysis session.
Measured: 3 weeks
Effect of high versus low protein meals during dialysis on patients nutritional status
Nutritional status will be calculated for each group (high versus low protein meals) using the Malnutrition-Inflammation Score (MIS). The Malnutrition-Inflamation score (MIS) is composed of 10 components which include: dry weight change over the last 3-6 months, current dietary intake, gastrointestinal symptoms, functional capacity (nutritionally related functional impairment), co-morbidity (including number of years on dialysis), decreased fat stores or loss of subcutaneous fat on physical examination (below eyes, triceps, biceps, chest), signs of muscle wasting (temple, clavicle, scapula, ribs, quadriceps, knee, interosseous), body mass index calculation, serum albumin levels, and serum total iron binding capacity. Each component of the MIS has 4 levels of severity, from 0 (normal) to 3 (severely abnormal). The sum of all 10 MIS components can range from 0 (normal) to 30 (severely malnourished); higher score reflects a more severe degree of malnutrition and inflammation.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2019
- Study start1 Aug 2019
- Primary completion1 Aug 2020 (estimated)
- Study completion1 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by Aristotle University Of ThessalonikiThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Open label, randomized, cross-over clinical study.
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vaios Vasileios, Aristotle University Of Thessaloniki
- Investigators
- Vassilios Liakopoulos, MD, PhD, Study chair, Department of Medicine, Aristotle University of ThessalonikiElena Fotiadou, Study director, Department of Nutrition and Dietetics, AHEPA University Hospital, Thessaloniki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03947710
- Sponsor's protocol ID
- MedAuth2
- Status last verified
- Jan 2020
- First submitted
- 8 May 2019
- Last updated
- 7 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Caglar K, Fedje L, Dimmitt R, Hakim RM, Shyr Y, Ikizler TA. Therapeutic effects of oral nutritional supplementation during hemodialysis. Kidney Int. 2002 Sep;62(3):1054-9. doi: 10.1046/j.1523-1755.2002.00530.x.
PubMed 12164890Burrowes JD, Larive B, Cockram DB, Dwyer J, Kusek JW, McLeroy S, Poole D, Rocco MV; Hemodialysis (HEMO) Study Group. Effects of dietary intake, appetite, and eating habits on dialysis and non-dialysis treatment days in hemodialysis patients: cross-sectional results from the HEMO study. J Ren Nutr. 2003 Jul;13(3):191-8. doi: 10.1016/s1051-2276(03)00069-4.
PubMed 12874743Rhee CM, You AS, Koontz Parsons T, Tortorici AR, Bross R, St-Jules DE, Jing J, Lee ML, Benner D, Kovesdy CP, Mehrotra R, Kopple JD, Kalantar-Zadeh K. Effect of high-protein meals during hemodialysis combined with lanthanum carbonate in hypoalbuminemic dialysis patients: findings from the FrEDI randomized controlled trial. Nephrol Dial Transplant. 2017 Jul 1;32(7):1233-1243. doi: 10.1093/ndt/gfw323.
PubMed 27659126Jansen RW, Lipsitz LA. Postprandial hypotension: epidemiology, pathophysiology, and clinical management. Ann Intern Med. 1995 Feb 15;122(4):286-95. doi: 10.7326/0003-4819-122-4-199502150-00009.
PubMed 7825766Choi MS, Kistler B, Wiese GN, Stremke ER, Wright AJ, Moorthi RN, Moe SM, Hill Gallant KM. Pilot Study of the Effects of High-Protein Meals During Hemodialysis on Intradialytic Hypotension in Patients Undergoing Maintenance Hemodialysis. J Ren Nutr. 2019 Mar;29(2):102-111. doi: 10.1053/j.jrn.2018.06.002. Epub 2018 Aug 11.
PubMed 30107974Kistler B, Benner D, Burgess M, Stasios M, Kalantar-Zadeh K, Wilund KR. To eat or not to eat-international experiences with eating during hemodialysis treatment. J Ren Nutr. 2014 Nov;24(6):349-52. doi: 10.1053/j.jrn.2014.08.003. Epub 2014 Oct 22.
PubMed 25443543Sarafidis PA, Georgianos PI, Karpetas A, Bikos A, Korelidou L, Tersi M, Divanis D, Tzanis G, Mavromatidis K, Liakopoulos V, Zebekakis PE, Lasaridis A, Protogerou AD. Evaluation of a novel brachial cuff-based oscillometric method for estimating central systolic pressure in hemodialysis patients. Am J Nephrol. 2014;40(3):242-50. doi: 10.1159/000367791. Epub 2014 Oct 11.
PubMed 25322847San Juan Miguelsanz M, Pilar SM, Santos de Pablos MR. Reduction of Kt/V by food intake during haemodialysis. EDTNA ERCA J. 2001 Jul-Sep;27(3):150-2. doi: 10.1111/j.1755-6686.2001.tb00165.x.
PubMed 11868999Borzou SR, Mahdipour F, Oshvandi K, Salavati M, Alimohammadi N. Effect of Mealtime During Hemodialysis on Patients' Complications. J Caring Sci. 2016 Dec 1;5(4):277-286. doi: 10.15171/jcs.2016.029. eCollection 2016 Dec.
PubMed 28032072Bossola M, Luciani G, Rosa F, Tazza L. Appetite and gastrointestinal symptoms in chronic hemodialysis patients. J Ren Nutr. 2011 Nov;21(6):448-54. doi: 10.1053/j.jrn.2010.09.003. Epub 2011 Jan 15.
PubMed 21239186Sherman RA, Torres F, Cody RP. Postprandial blood pressure changes during hemodialysis. Am J Kidney Dis. 1988 Jul;12(1):37-9. doi: 10.1016/s0272-6386(88)80069-6.
PubMed 3389352Heymsfield SB, McManus C, Smith J, Stevens V, Nixon DW. Anthropometric measurement of muscle mass: revised equations for calculating bone-free arm muscle area. Am J Clin Nutr. 1982 Oct;36(4):680-90. doi: 10.1093/ajcn/36.4.680.
PubMed 7124671Frisancho AR. New norms of upper limb fat and muscle areas for assessment of nutritional status. Am J Clin Nutr. 1981 Nov;34(11):2540-5. doi: 10.1093/ajcn/34.11.2540.
PubMed 6975564Durnin JV, Womersley J. Body fat assessed from total body density and its estimation from skinfold thickness: measurements on 481 men and women aged from 16 to 72 years. Br J Nutr. 1974 Jul;32(1):77-97. doi: 10.1079/bjn19740060. No abstract available.
PubMed 4843734Malindretos P, Sarafidis P, Spaia S, Sioulis A, Zeggos N, Raptis V, Kitos V, Koronis C, Kabouris C, Zili S, Grekas D. Adaptation and validation of the Kidney Disease Quality of Life-Short Form questionnaire in the Greek language. Am J Nephrol. 2010;31(1):9-14. doi: 10.1159/000252926. Epub 2009 Oct 26.
PubMed 19864884
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effect of Protein Intake During Dialysis on Intradialytic Blood Pressure, 24-hour Ambulatory Blood Pressure and Arterial Stiffness Indices in Maintenance Hemodialysis Patients.
- ClinicalTrials.gov ID
- NCT03947710
- Acronym / sponsor ID
- MedAuth2
- Conditions
- End Stage Renal Disease, Hypotension During Dialysis, Protein Malnutrition, Arterial Sclerosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 1 Aug 2020 (estimated)
- Study completion
- 1 Aug 2020 (estimated)
- First posted
- 13 May 2019 (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.
Open label, randomized, cross-over clinical study comparing the acute effect of high versus low protein meals during dialysis on intradialytic blood pressure, 24-hour ambulatory blood pressure and arterial stiffness indices on maintenance hemodialysis patients.
Detailed description
A series of demographic, anthropometric and clinical data will be collected prior to enrollment. The intervention will last 3 consecutive weeks. Eligible subjects will be randomised to one group (high or low protein meals during dialysis) for one week (3 dialysis sessions). Second week will be a wash out period (patients will not consume meals during dialysis) and during the third week randomised subjects will cross over to the other study group. Every meal will provide 1/3 of daily recommended energy and protein intake (35 kcal/kg body weight/day, 0.7 gr protein/kg body weight/day for low protein meals and 1.5 gr protein/kg body weight/day for high protein meals). All the meals will be prepared in the hospital's kitchen and will be personalized to each patient's preferences. The meal will be given one hour after the start of the session and should be consumed completely during dialysis.
Patients will be evaluated for the following parameters during their midweek dialysis session:
- Intradialytic blood pressure
- 24-hour ambulatory blood pressure
- Arterial stiffness indices (Central Aortic blood pressure, Pulse Wave Velocity, Augmentation Index)
- Hemodialysis adequacy
- Nutritional status
Intradialytic blood pressure, 24-hour ambulatory blood pressure and arterial stiffness indices will be evaluated with the use of the brachial cuff-based oscillometric device Mobil-O-Graph NG (IEM, Stolberg, Germany). Urea reduction ratio (URR) and Kt/V (standard and equilibrated) will be used as measures for dialysis adequacy. Possible changes in patients nutritional status will be assessed using the Malnutrition-Inflammation Score (MIS).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Open label, randomized, cross-over clinical study.
| Arm | Type | Receives |
|---|---|---|
| High-protein meals | Experimental | Other: High-protein mealsPatients with End Stage Renal disease on maintenance hemodialysis will consume high protein meals during their dialysis sessions for one week. |
| Low-protein meals | Experimental | Other: Low- protein mealsPatients with End Stage Renal disease on maintenance hemodialysis will consume low protein meals during their dialysis sessions for one week |
| No meals | Experimental | Other: No mealsPatients with End Stage Renal disease on maintenance hemodialysis will not consume meals during their dialysis sessions for one week |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients to have provided informed written consent
- Patients undergoing maintenance hemodialysis for at least 3 months prior to enrollment
- Ability to self-ingest food during the dialysis session
Key exclusion criteria (8 listed)
- History of malignancy or any other clinical condition associated with very poor prognosis
- Hospitalization for acute myocardial infarction, unstable angina or acute ischemic stroke within the 3 previous months
- Patients receiving parenteral nutrition
- Body mass index (BMI) of >40 kg/m2
- Bilateral functioning or non-functioning arteriovenous fistula (AVF) and/or arteriovenous graft (AVG) used as dialysis access
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 |
|---|---|---|
| High-protein mealsPatients on maintenance hemodialysis will consume high protein meals during dialysis for one week (3 dialysis sessions) | Other | High-protein meals |
| Low- protein mealsPatients on maintenance hemodialysis will consume low protein meals during dialysis for one week (3 dialysis sessions) | Other | Low-protein meals |
| No mealsPatients on maintenance hemodialysis will not consume meals during dialysis for one week (3 dialysis sessions) | Other | No meals |
Primary outcome
Effect of meal versus no meal consumption during hemodialysis on intradialytic blood pressure
Time frame: 3 weeks
Meal consumption is expected to lower intradialytic blood pressure and increase hypotensive events during hemodialysis. Intradialytic blood pressure will be evaluated with the use of the brachial cuff-based oscillometric device Mobil-O-Graph NG (IEM, Stolberg, Germany) during the midweek dialysis session.
Effect of high versus low protein meal consumption during dialysis on intradialytic blood pressure
Time frame: 3 weeks
High protein meals are expected to affect less intradialytic blood pressure than low protein meals. Intradialytic blood pressure will be evaluated with the use of the brachial cuff-based oscillometric device Mobil-O-Graph NG (IEM, Stolberg, Germany) during the midweek dialysis session.
5 secondary outcomes
Effect of high versus low protein meal consumption during dialysis on 24-hour ambulatory blood pressure
Time frame: 3 weeks
Effect of high versus low protein meal consumption during dialysis on Pulse Wave Velocity
Time frame: 3 weeks
Effect of high versus low protein meal consumption during dialysis on Augmentation Index
Time frame: 3 weeks
Effect of high versus low protein meals during dialysis on hemodialysis adequacy.
Time frame: 3 weeks
Effect of high versus low protein meals during dialysis on patients nutritional status
Time frame: 3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2020.
- Background: PubMed 12164890Caglar K, Fedje L, Dimmitt R, Hakim RM, Shyr Y, Ikizler TA. Therapeutic effects of oral nutritional supplementation during hemodialysis. Kidney Int. 2002 Sep;62(3):1054-9. doi: 10.1046/j.1523-1755.2002.00530.x.
- Background: PubMed 12874743Burrowes JD, Larive B, Cockram DB, Dwyer J, Kusek JW, McLeroy S, Poole D, Rocco MV; Hemodialysis (HEMO) Study Group. Effects of dietary intake, appetite, and eating habits on dialysis and non-dialysis treatment days in hemodialysis patients: cross-sectional results from the HEMO study. J Ren Nutr. 2003 Jul;13(3):191-8. doi: 10.1016/s1051-2276(03)00069-4.
- Background: PubMed 27659126Rhee CM, You AS, Koontz Parsons T, Tortorici AR, Bross R, St-Jules DE, Jing J, Lee ML, Benner D, Kovesdy CP, Mehrotra R, Kopple JD, Kalantar-Zadeh K. Effect of high-protein meals during hemodialysis combined with lanthanum carbonate in hypoalbuminemic dialysis patients: findings from the FrEDI randomized controlled trial. Nephrol Dial Transplant. 2017 Jul 1;32(7):1233-1243. doi: 10.1093/ndt/gfw323.
- Background: PubMed 7825766Jansen RW, Lipsitz LA. Postprandial hypotension: epidemiology, pathophysiology, and clinical management. Ann Intern Med. 1995 Feb 15;122(4):286-95. doi: 10.7326/0003-4819-122-4-199502150-00009.
- Background: PubMed 30107974Choi MS, Kistler B, Wiese GN, Stremke ER, Wright AJ, Moorthi RN, Moe SM, Hill Gallant KM. Pilot Study of the Effects of High-Protein Meals During Hemodialysis on Intradialytic Hypotension in Patients Undergoing Maintenance Hemodialysis. J Ren Nutr. 2019 Mar;29(2):102-111. doi: 10.1053/j.jrn.2018.06.002. Epub 2018 Aug 11.
- Background: PubMed 25443543Kistler B, Benner D, Burgess M, Stasios M, Kalantar-Zadeh K, Wilund KR. To eat or not to eat-international experiences with eating during hemodialysis treatment. J Ren Nutr. 2014 Nov;24(6):349-52. doi: 10.1053/j.jrn.2014.08.003. Epub 2014 Oct 22.
- Background: PubMed 25322847Sarafidis PA, Georgianos PI, Karpetas A, Bikos A, Korelidou L, Tersi M, Divanis D, Tzanis G, Mavromatidis K, Liakopoulos V, Zebekakis PE, Lasaridis A, Protogerou AD. Evaluation of a novel brachial cuff-based oscillometric method for estimating central systolic pressure in hemodialysis patients. Am J Nephrol. 2014;40(3):242-50. doi: 10.1159/000367791. Epub 2014 Oct 11.
- Background: PubMed 11868999San Juan Miguelsanz M, Pilar SM, Santos de Pablos MR. Reduction of Kt/V by food intake during haemodialysis. EDTNA ERCA J. 2001 Jul-Sep;27(3):150-2. doi: 10.1111/j.1755-6686.2001.tb00165.x.
- Background: PubMed 28032072Borzou SR, Mahdipour F, Oshvandi K, Salavati M, Alimohammadi N. Effect of Mealtime During Hemodialysis on Patients' Complications. J Caring Sci. 2016 Dec 1;5(4):277-286. doi: 10.15171/jcs.2016.029. eCollection 2016 Dec.
- Background: PubMed 21239186Bossola M, Luciani G, Rosa F, Tazza L. Appetite and gastrointestinal symptoms in chronic hemodialysis patients. J Ren Nutr. 2011 Nov;21(6):448-54. doi: 10.1053/j.jrn.2010.09.003. Epub 2011 Jan 15.
- Background: PubMed 3389352Sherman RA, Torres F, Cody RP. Postprandial blood pressure changes during hemodialysis. Am J Kidney Dis. 1988 Jul;12(1):37-9. doi: 10.1016/s0272-6386(88)80069-6.
- Background: PubMed 7124671Heymsfield SB, McManus C, Smith J, Stevens V, Nixon DW. Anthropometric measurement of muscle mass: revised equations for calculating bone-free arm muscle area. Am J Clin Nutr. 1982 Oct;36(4):680-90. doi: 10.1093/ajcn/36.4.680.
- Individual participant dataSharing planned: No
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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.
Vassilios Liakopoulos, MD, PhD study chair
Department of Medicine, Aristotle University of Thessaloniki
Elena Fotiadou study director
Department of Nutrition and Dietetics, AHEPA University Hospital, Thessaloniki
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-protein meals, Low- protein meals and No meals in people with End Stage Renal Disease and Hypotension During Dialysis, run by Aristotle University Of Thessaloniki at 1 site in Greece.
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 8 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: status not confirmed, as of the sponsor's last update on 7 Jan 2020. 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 Greece. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vasileios Vaios, MD (+306984568904, vvaios_85@yahoo.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of meal versus no meal consumption during hemodialysis on intradialytic blood pressure (time frame: 3 weeks). 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 NCT03947710, which also lists 16 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 7 Jan 2020; AzTrials last refreshed its copy on 8 Nov 2026.