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

January 6, 2020 updated by: Vaios Vasileios, Aristotle University Of Thessaloniki

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
    • Select A State/Province
      • Thessaloniki, Select A State/Province, Greece, 54636
        • Recruiting
        • Ahepa University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 weeks
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.
3 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
3 weeks
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 weeks
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).
3 weeks
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.
3 weeks
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.
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aristotle University Of Thessaloniki

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 1, 2019

Primary Completion (ANTICIPATED)

August 1, 2020

Study Completion (ANTICIPATED)

August 1, 2020

Study Registration Dates

First Submitted

May 8, 2019

First Submitted That Met QC Criteria

May 9, 2019

First Posted (ACTUAL)

May 13, 2019

Study Record Updates

Last Update Posted (ACTUAL)

January 7, 2020

Last Update Submitted That Met QC Criteria

January 6, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MedAuth2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on End Stage Renal Disease

Clinical Trials on High-protein meals

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cameroon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe