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出境医 / 临床实验 / Effect of Protein Intake During Hemodialysis on Blood Pressure and Arterial Stiffness Indices

Effect of Protein Intake During Hemodialysis on Blood Pressure and Arterial Stiffness Indices

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
End Stage Renal Disease Hypotension During Dialysis Protein Malnutrition Arterial Sclerosis Other: High-protein meals Other: Low- protein meals Other: No meals Not Applicable

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:

  1. Intradialytic blood pressure
  2. 24-hour ambulatory blood pressure
  3. Arterial stiffness indices (Central Aortic blood pressure, Pulse Wave Velocity, Augmentation Index)
  4. Hemodialysis adequacy
  5. 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
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Open label, randomized, cross-over clinical study.
Masking: None (Open Label)
Primary Purpose: Prevention
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.
Actual Study Start Date : August 1, 2019
Estimated Primary Completion Date : August 1, 2020
Estimated Study Completion Date : August 1, 2020
Arms and Interventions
Arm Intervention/treatment
Experimental: High-protein meals
Patients with End Stage Renal disease on maintenance hemodialysis will consume high protein meals during their dialysis sessions for one week.
 Other: High-protein meals
Patients on maintenance hemodialysis will consume high protein meals during dialysis for one week (3 dialysis sessions)
Experimental: Low-protein meals
Patients with End Stage Renal disease on maintenance hemodialysis will consume low protein meals during their dialysis sessions for one week
 Other: Low- protein meals
Patients on maintenance hemodialysis will consume low protein meals during dialysis for one week (3 dialysis sessions)
Experimental: No meals
Patients with End Stage Renal disease on maintenance hemodialysis will not consume meals during their dialysis sessions for one week
 Other: No meals
Patients on maintenance hemodialysis will not consume meals during dialysis for one week (3 dialysis sessions)
Outcome Measures
Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Effect of high versus low protein meal consumption during dialysis on 24-hour ambulatory blood pressure [ Time Frame: 3 weeks ]
    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).

  2. Effect of high versus low protein meal consumption during dialysis on Pulse Wave Velocity [ Time Frame: 3 weeks ]
    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).

  3. Effect of high versus low protein meal consumption during dialysis on Augmentation Index [ Time Frame: 3 weeks ]
    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).

  4. Effect of high versus low protein meals during dialysis on hemodialysis adequacy. [ Time Frame: 3 weeks ]
    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.

  5. Effect of high versus low protein meals during dialysis on patients nutritional status [ Time Frame: 3 weeks ]
    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.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Vasileios Vaios, MD +306984568904 vvaios_85@yahoo.gr

Locations
Layout table for location information
Greece
AHEPA University Hospital Recruiting
Thessaloniki, Select A State/Province, Greece, 54636
Contact: Vassilios Liakopoulos    6932293544    liakopul@otenet.gr   
Sponsors and Collaborators
Aristotle University Of Thessaloniki
Investigators
Layout table for investigator information
Study Chair: Vassilios Liakopoulos, MD, PhD Department of Medicine, Aristotle University of Thessaloniki
Study Director: Elena Fotiadou Department of Nutrition and Dietetics, AHEPA University Hospital, Thessaloniki
Tracking Information
First Submitted Date  ICMJE May 8, 2019
First Posted Date  ICMJE May 13, 2019
Last Update Posted Date January 7, 2020
Actual Study Start Date  ICMJE August 1, 2019
Estimated Primary Completion Date August 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 9, 2019)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 10, 2019)
  • Effect of high versus low protein meal consumption during dialysis on 24-hour ambulatory blood pressure [ Time Frame: 3 weeks ]
    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).
  • Effect of high versus low protein meal consumption during dialysis on Pulse Wave Velocity [ Time Frame: 3 weeks ]
    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).
  • Effect of high versus low protein meal consumption during dialysis on Augmentation Index [ Time Frame: 3 weeks ]
    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).
  • Effect of high versus low protein meals during dialysis on hemodialysis adequacy. [ Time Frame: 3 weeks ]
    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.
  • Effect of high versus low protein meals during dialysis on patients nutritional status [ Time Frame: 3 weeks ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 9, 2019)
  • Effect of high versus low protein meal consumption during dialysis on 24-hour ambulatory blood pressure [ Time Frame: 3 weeks ]
    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).
  • Effect of high versus low protein meal consumption during dialysis on Pulse Wave Velocity [ Time Frame: 3 weeks ]
    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).
  • Effect of high versus low protein meal consumption during dialysis on Augmentation Index [ Time Frame: 3 weeks ]
    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).
  • Effect of high versus low protein meals during dialysis on hemodialysis adequacy. [ Time Frame: 3 weeks ]
    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.
  • Effect of high versus low protein meals during dialysis on patients nutritional status [ Time Frame: 3 weeks ]
    Nutritional status will be calculated for each group (high versus low protein meals) using the Malnutrition-Inflammation Score (MIS).
  • Effect of feeding during dialysis on symptoms of gastrointestinal discomfort [ Time Frame: 3 weeks ]
    The presence of certain symptoms of gastrointestinal discomfort will be assesed for each group (meal versus no meal consumption) using a Likert-scale questionnaire.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Protein Intake During Hemodialysis on Blood Pressure and Arterial Stiffness Indices
Official Title  ICMJE Acute Effect of Protein Intake During Dialysis on Intradialytic Blood Pressure, 24-hour Ambulatory Blood Pressure and Arterial Stiffness Indices in Maintenance Hemodialysis Patients.
Brief 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.
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:

  1. Intradialytic blood pressure
  2. 24-hour ambulatory blood pressure
  3. Arterial stiffness indices (Central Aortic blood pressure, Pulse Wave Velocity, Augmentation Index)
  4. Hemodialysis adequacy
  5. 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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
Open label, randomized, cross-over clinical study.
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • End Stage Renal Disease
  • Hypotension During Dialysis
  • Protein Malnutrition
  • Arterial Sclerosis
Intervention  ICMJE
  • Other: High-protein meals
    Patients on maintenance hemodialysis will consume high protein meals during dialysis for one week (3 dialysis sessions)
  • Other: Low- protein meals
    Patients on maintenance hemodialysis will consume low protein meals during dialysis for one week (3 dialysis sessions)
  • Other: No meals
    Patients on maintenance hemodialysis will not consume meals during dialysis for one week (3 dialysis sessions)
Study Arms  ICMJE
  • Experimental: High-protein meals
    Patients with End Stage Renal disease on maintenance hemodialysis will consume high protein meals during their dialysis sessions for one week.
    Intervention: Other: High-protein meals
  • Experimental: Low-protein meals
    Patients with End Stage Renal disease on maintenance hemodialysis will consume low protein meals during their dialysis sessions for one week
    Intervention: Other: Low- protein meals
  • Experimental: No meals
    Patients with End Stage Renal disease on maintenance hemodialysis will not consume meals during their dialysis sessions for one week
    Intervention: Other: No meals
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.
  • Burrowes 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.
  • Rhee 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.
  • Jansen RW, Lipsitz LA. Postprandial hypotension: epidemiology, pathophysiology, and clinical management. Ann Intern Med. 1995 Feb 15;122(4):286-95. Review.
  • Choi 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.
  • Kistler 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.
  • Sarafidis 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.
  • San 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.
  • Borzou 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.
  • Bossola 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.
  • Sherman RA, Torres F, Cody RP. Postprandial blood pressure changes during hemodialysis. Am J Kidney Dis. 1988 Jul;12(1):37-9.
  • Heymsfield 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.
  • Frisancho 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.
  • Durnin 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.
  • Malindretos 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.
  • Agarwal R, Georgianos P. Feeding during dialysis-risks and uncertainties. Nephrol Dial Transplant. 2018 Jun 1;33(6):917-922. doi: 10.1093/ndt/gfx195. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 9, 2019) 		45
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 1, 2020
Estimated Primary Completion Date August 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Vasileios Vaios, MD +306984568904 vvaios_85@yahoo.gr
Listed Location Countries  ICMJE Greece
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03947710
Other Study ID Numbers  ICMJE MedAuth2
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Vaios Vasileios, Aristotle University Of Thessaloniki
Study Sponsor  ICMJE Aristotle University Of Thessaloniki
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Vassilios Liakopoulos, MD, PhD Department of Medicine, Aristotle University of Thessaloniki
Study Director: Elena Fotiadou Department of Nutrition and Dietetics, AHEPA University Hospital, Thessaloniki
PRS Account Aristotle University Of Thessaloniki
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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