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IRCT20210427051098N5 IRCT 2023-12-11 Yazd University of Medical Sciences Investigating the effect of diet based on the global diet quality score in hemodialysis 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 2023-12-22 anticipated 50 Complete https://irct.ir/trial/73124 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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. N/A individuals with chronic kidney disease under hemodialysis. Intervention 1: Intervention group: In the GDQS-based diet group, people undergoing hemodialysis treatment will receive GDQS diet training for 12 weeks (one training session per week) and each session will last 10 minutes. The amount of prescribed energy intake for people is calculated according to the Harris-Benedict equation. (22) If the body mass index of people is less than 25, the current weight of people is used to calculate energy; But if the body mass index is more than 25, the adjusted weight of people according to the body mass index of 25 is used to calculate energy. In the control group, the standard diet of hemodialysis patients will be set for the patients and they will be taught by nutrition experts.The GDQS is a completely food-based measure of 25 food groups: 16 healthy food groups, 7 unhealthy food groups, and 2 food groups (red meat, full-fat dairy) that are unhealthy if consumed in excess. For the 24 GDQS food groups, three ranges of intake are defined (in grams per day) and used in scoring the metric: low, moderate, and high. For a food group (full-fat dairy), four ranges of consumption are used: low, medium, high, and very high.The diet will be adjusted based on the recommendations of GDQS according to the amount of energy needed by the person. In designing this diet, get more dark green leafy vegetables, cabbage family, orange root vegetables (carrots, sweet potatoes, acorns, pumpkins, and pumpkins) and other vegetables, orange fruits (persimmons, apricots, nectarines, cantaloupe and.), citrus fruits and other fruits, legumes, nuts and seeds, poultry meat, lamb and fish, whole grains, liquid oils, low-fat dairy products, and eggs and reducing the intake of root vegetables and white tubers ( All kinds of turnips and radishes, yolks and .), processed meats, refined grains and toasted bread, sweets, and drinks sweetened with sugar, ice cream, juices and fried foods and especially high-fat dairy products and red meat are emphasized. In the training sessions, the GDQS dietary recommendations will be fully explained to the individuals. These recommendations will be based on the economic status people's access to food and the status of some other diseases such as digestive diseases. People can communicate with experts through phone calls or messengers during the 12 weeks of intervention. Intervention 2: Control group: In the control group, the standard diet will be designed based on the dietary guidelines of the people undergoing hemodialysis treatment for the people in the control group. The percentage of protein intake will be considered as 1.2 grams per kilogram of people's weight, and after calculating the percentage of protein, the percentage of other macronutrients will also be determined, and based on that, the standard diet will be designed. Individuals can stay in touch with experts through phone calls or messengers during the 12 weeks of intervention. The number of training sessions in the standard diet group will be 12 sessions. Yes - There is a plan to make this available What will be shared: primary outcome will be available at the end of study When: From January 2024 To whom: Academic institutions Conditions: 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. Where to obtain: Sayyed Saeid Khayyatzadeh Assistant professor of nutrition in Shahid Sadoughi university of medical sciences Khayyatzadeh@yahoo.com 00983538209100 How to obtain: 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 Comments:
public Sara Bagherpour
Department of Nutrition, Faculty of Health, Shahid Sadoughi University of Medical Sciences, Alam Square, Yazd City
Yazd Iran (Islamic Republic of) 8915173160 +98 35 3149 2228 sarabagherpour1376@gmail.com Yazd University of Medical Sciences scientific Sayyed Saeid Khayyatzadeh
Department of Nutrition, Faculty of Health, Shahid Sadoughi University of Medical Sciences, Alam Square, Yazd City
Yazd Iran (Islamic Republic of) 891618863 +98 35 3149 2228 khayyatzadeh@yahoo.com Yazd University of Medical Sciences Iran (Islamic Republic of) Individuals under hemodialysis (at least 2 times a week) for at least 1 months or more Completion of informed consent 18 years 70 years Both History of cancer Suffering from hepatitis Suffering from liver cancer Taking medications for liver disease Having a specific perception or psychological disorder Immunodeficiency AIDS Suffering from a severe inflammatory disease Pregnancy Lactation I95.3 Hypotension of hemodialysis N/A N/A Intervention group: In the GDQS-based diet group, people undergoing hemodialysis treatment will receive GDQS diet training for 12 weeks (one training session per week) and each session will last 10 minutes. The amount of prescribed energy intake for people is calculated according to the Harris-Benedict equation. (22) If the body mass index of people is less than 25, the current weight of people is used to calculate energy; But if the body mass index is more than 25, the adjusted weight of people according to the body mass index of 25 is used to calculate energy. In the control group, the standard diet of hemodialysis patients will be set for the patients and they will be taught by nutrition experts.The GDQS is a completely food-based measure of 25 food groups: 16 healthy food groups, 7 unhealthy food groups, and 2 food groups (red meat, full-fat dairy) that are unhealthy if consumed in excess. For the 24 GDQS food groups, three ranges of intake are defined (in grams per day) and used in scoring the metric: low, moderate, and high. For a food group (full-fat dairy), four ranges of consumption are used: low, medium, high, and very high.The diet will be adjusted based on the recommendations of GDQS according to the amount of energy needed by the person. In designing this diet, get more dark green leafy vegetables, cabbage family, orange root vegetables (carrots, sweet potatoes, acorns, pumpkins, and pumpkins) and other vegetables, orange fruits (persimmons, apricots, nectarines, cantaloupe and.), citrus fruits and other fruits, legumes, nuts and seeds, poultry meat, lamb and fish, whole grains, liquid oils, low-fat dairy products, and eggs and reducing the intake of root vegetables and white tubers ( All kinds of turnips and radishes, yolks and .), processed meats, refined grains and toasted bread, sweets, and drinks sweetened with sugar, ice cream, juices and fried foods and especially high-fat dairy products and red meat are emphasized. In the training sessions, the GDQS dietary recommendations will be fully explained to the individuals. These recommendations will be based on the economic status people's access to food and the status of some other diseases such as digestive diseases. People can communicate with experts through phone calls or messengers during the 12 weeks of intervention. Control group: In the control group, the standard diet will be designed based on the dietary guidelines of the people undergoing hemodialysis treatment for the people in the control group. The percentage of protein intake will be considered as 1.2 grams per kilogram of people's weight, and after calculating the percentage of protein, the percentage of other macronutrients will also be determined, and based on that, the standard diet will be designed. Individuals can stay in touch with experts through phone calls or messengers during the 12 weeks of intervention. The number of training sessions in the standard diet group will be 12 sessions Creatinine. Timepoint: Before the intervention, 12 weeks after the intervention. Method of measurement: Pars Azmoun biochemical kit. Blood urea nitrogen (BUN). Timepoint: Before the intervention, 12 weeks after the intervention. Method of measurement: Pars Azmoun biochemical kit. Serum Albumin. Timepoint: Before the intervention, 12 weeks after the intervention. Method of measurement: Pars Azmoun biochemical kit. Alkaline phosphatase. Timepoint: Before the intervention, 12 weeks after the intervention. Method of measurement: Pars Azmoun biochemical kit. Parathormone. Timepoint: Before the intervention, 12 weeks after the intervention. Method of measurement: Pars Azmoun biochemical kit. Total bilirubin. Timepoint: Before the intervention, 12 weeks after the intervention. Method of measurement: Pars Azmoun biochemical kit. Direct bilirubin. Timepoint: Before the intervention, 12 weeks after the intervention. Method of measurement: Pars Azmoun biochemical kit. Sodium. Timepoint: Before the intervention, 12 weeks after the intervention. Method of measurement: Pars Azmoun biochemical kit. Potassium. Timepoint: Before the intervention, 12 weeks after the intervention. Method of measurement: Pars Azmoun biochemical kit. Phosphorus. Timepoint: Before the intervention, 12 weeks after the intervention. Method of measurement: Pars Azmoun biochemical kit. Calcium. Timepoint: Before the intervention, 12 weeks after the intervention. Method of measurement: Pars Azmoun biochemical kit. Fasting Blood Glucose. Timepoint: Before the intervention, 12 weeks after the intervention. Method of measurement: Pars Azmoun biochemical kit. Total cholesterol. Timepoint: Before the intervention, 12 weeks after the intervention. Method of measurement: Pars Azmoun biochemical kit. Triglyceride. Timepoint: Before the intervention, 12 weeks after the intervention. Method of measurement: Pars Azmoun biochemical kit. Depression. Timepoint: Before the intervention, 12 weeks after the intervention. Method of measurement: Validated hospital anxiety and depression questionnaire. Anxiety. Timepoint: Before the intervention, 12 weeks after the intervention. Method of measurement: Validated hospital anxiety and depression questionnaire. Sleep quality. Timepoint: Before the intervention, 12 weeks after the intervention. Method of measurement: Validated Pittsburgh questionnaire. Quality of Life. Timepoint: Before the intervention, 12 weeks after the intervention. Method of measurement: Validated KDQOL-36 questionnaire. Fatigue. Timepoint: Before the intervention, 12 weeks after the intervention. Method of measurement: Piper's validated fatigue questionnaire and scale. Weight. Timepoint: Before the intervention, 12 weeks after the intervention. Method of measurement: Weighting scale. Body Mass Index (BMI). Timepoint: Before the intervention, 12 weeks after the intervention. Method of measurement: Body composition analyzer. Waist circumference. Timepoint: Before the intervention, 12 weeks after the intervention. Method of measurement: Tape measure. Hips circumference. Timepoint: Before the intervention, 12 weeks after the intervention. Method of measurement: Tape measure. Fat mass. Timepoint: Before the intervention, 12 weeks after the intervention. Method of measurement: Body composition analyzer. Fat free mass. Timepoint: Before the intervention, 12 weeks after the intervention. Method of measurement: Body composition analyzer. Blood pressure. Timepoint: Before the intervention, 12 weeks after the interventio. Method of measurement: Measurement of systolic and diastolic blood pressure (mmHg). Yazd University of Medical Sciences Approved 2023-11-25 Ethics Committee of Shahid Sadoughi University of Medical Sciences hahid Sadoughi University of Medical Sciences and Health Services Campus- Shohadaye Gomnam Blvd- Alem Square- Yazd Yazd Yazd Iran (Islamic Republic of)