Investigating the effect of Global Diet Quality Score (GDQS) compared to the control diet (diet for hemodialysis patients) on the levels of creatinine (Cr), blood urea nitrogen (BUN) and serum electrolytes in individuals with chronic kidney disease under hemodialysis: A randomized clinical trial study

Determining the effect of diet based on the Global Diet Quality Score (GDQS) compared to the control diet (the diet of hemodialysis patients) on the levels of creatinine (Cr), blood urea nitrogen (BUN) and serum electrolytes in people with chronic diseases Kidney under hemodialysis: a randomized clinical trial study

A randomized, parallel, controlled clinical trial. The number of 50 eligible participants to participate in the study will be divided into one of 2 intervention and control groups (n=25) using a simple randomization method

This study will be done in Shahid Rahmonun and Goodarz Hospital, Yazd. A total of 50 eligible people will be randomly assigned to 2 groups for 3 months to receive GDQS or standard dietary recommendations. At the beginning of the study and after 3 months from the start of the study, creatinine, blood urea nitrogen, serum electrolytes will be evaluated. Due to the nature of the study, blinding was not done.

Adults with the age range of 18 to 70 years and undergoing hemodialysis treatment (at least 2 times a week) for at least 1 months and more who complete the consent form to enter the study. Exclusion criteria: pregnant and lactating women, people with a history of Cancer, liver disease, cognitive or psychological disorder, immunodeficiency, AIDS and severe inflammatory disease.

Individuals will receive the GDQS diet. Participants will learn the GDQS diet in 12 face-to-face sessions. They will also receive GDQS dietary advice during the course. Control group: subjects will receive standard diet. Participants will be taught the standard diet in 12 face-to-face sessions. They will also receive standard dietary advice throughout the course. The duration of intervention and study will be 3 months

creatinine, blood urea nitrogen, serum electrolytes

After determining the eligible people and receiving ethical consent, people will be divided into two groups (intervention: GDQS-based diet or control: standard diet) by random allocation method. At first, each person will receive a unique code. Then all the codes will enter the Random Allocation software. Software inputs will include the total number of samples and the number of treatment groups (intervention and control). The output of the software will include random numbers assigned for both groups. The distribution ratio of people will be 1 to 1. Each person has an equal chance to be placed in each of the groups, and the participants cannot predict which group they will be placed in. Randomization will be done as a block classification based on gender (male and female) and BMI (higher and lower than 25) and in a block with a block size equal to 6.

primary outcome will be available at the end of study

From January 2024

Academic institutions

Academic institutes can send their official request to the email of the scientific director of the project. the data will be sent after confirmation of ethics committee of shahid sadoughi university of medical sciences. It is not possible to perform statistical analysis on the data.

Sayyed Saeid Khayyatzadeh Assistant professor of nutrition in Shahid Sadoughi university of medical sciences Khayyatzadeh@yahoo.com 00983538209100

Academic institutes can send their official request to the email of the scientific director of the project. The data will be sent after confirmation of ethics committee of Shahid Sadoughi university of medical sciences