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IRCT20211027052884N1 IRCT 2021-11-09 Tehran University of Medical Sciences The effect of the Mediterranean diet on nutritional status, muscle mass and strength, and inflammatory factors in patients with colorectal cancer cachexia: A randomized controlled clinical trial The effect of the Mediterranean diet on nutritional status, muscle mass and strength, and inflammatory factors in patients with colorectal cancer cachexia: A randomized controlled clinical trial 2021-12-22 anticipated 40 Complete https://irct.ir/trial/59615 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Stratified block randomization will be performed based on the type of cancer (colon or rectum) using the site www.randomization.com. In this method, each group will be assigned one of the letters A and B, and randomization will be done in 4 blocks. This will be done for each type of cancer (colon or rectum) and two lists will be prepared for them. Within each class, patients will be randomly assigned to one of the two study groups in a 1: 1 ratio. The randomization process will be performed by someone outside the research team. N/A Colorectal cancer cachexia. Intervention 1: Intervention group: Participants in the intervention group will receive a Mediterranean diet menu. For this purpose, the energy required by the patients in the intervention group, according to the recommendations of the ASPEN guideline, is first considered 25 kcal per kg of body weight (current weight of patients), and then gradually over two weeks, this amount will be considered up to 35 kcal per kg of body weight. This calorie will be divided as follows: 35% of calories from fat, 45% of calories from carbohydrates, and 20% of calories from protein. Then, the sources of these macronutrients from different food groups will be considered based on the Mediterranean diet pyramid. Moreover, based on these food groups, a weekly menu will be set up for patients. To follow this diet, extra virgin olive oil will be given to patients. Intervention 2: Control group: Participants in the control group will receive nutritional advice for cancer patients and dietary recommendations for weight gain. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is It is not yet known if there will be a plan to make this available
public Amir Bagheri
Faculty of Nutrition and Dietetics, No. 44, Hojjatdoost Alley, Naderi St., Keshavarz Blvd., Keshavarz Blvd., Tehran University of Medical Sciences and Health Services
Tehran Iran (Islamic Republic of) 1416643931 +98 21 8895 5975 abaqeri@razi.tums.ac.ir Tehran University of Medical Sciences scientific Dr Ahmad Esmaillzadeh
Faculty of Nutrition and Dietetics, No. 44, Hojjatdoost Alley, Naderi St., Keshavarz Blvd., Keshavarz Blvd., Tehran University of Medical Sciences and Health Services
Tehran Iran (Islamic Republic of) 1416643931 +98 21 8895 5975 a.esmaillzadeh@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Patients with colorectal cancers in stages III-IV according to TNM UICC 2010 method (based on the oncologist diagnosis). The patient has cachexia, which is defined according to the Global Leadership Initiative on Malnutrition (GLIM). Patients' functional status is at least ≥ 70% according to Karnofsky scale. Individuals who have no contraindications for oral feeding and be able to be fed orally. Patients without acute uncontrolled underlying diseases such as kidney and/or liver failure. 40 years no limit Both Patients who need supportive nutrition such as enteral or parenteral feeding. Patients with a history of allergy to any components of the Mediterranean diet, such as olive oil or nuts. R64 Cachexia Lifestyle Lifestyle Intervention group: Participants in the intervention group will receive a Mediterranean diet menu. For this purpose, the energy required by the patients in the intervention group, according to the recommendations of the ASPEN guideline, is first considered 25 kcal per kg of body weight (current weight of patients), and then gradually over two weeks, this amount will be considered up to 35 kcal per kg of body weight. This calorie will be divided as follows: 35% of calories from fat, 45% of calories from carbohydrates, and 20% of calories from protein. Then, the sources of these macronutrients from different food groups will be considered based on the Mediterranean diet pyramid. Moreover, based on these food groups, a weekly menu will be set up for patients. To follow this diet, extra virgin olive oil will be given to patients. Control group: Participants in the control group will receive nutritional advice for cancer patients and dietary recommendations for weight gain Nutritional status score. Timepoint: Before the intervention - 8 weeks after the intervention. Method of measurement: PG-SGA (Patient Generated-Subjective Global Assessment) questionnaire. Muscle strength. Timepoint: Before the intervention - 8 weeks after the intervention. Method of measurement: Handgrip strength dynamometer. Muscle mass. Timepoint: Before the intervention - 8 weeks after the intervention. Method of measurement: Bio-Electrical Impedance Analysis (BIA). Inflammatory markers (hs-CRP, IL-6, TNF-α). Timepoint: Before the intervention - 8 weeks after the intervention. Method of measurement: enzyme-linked immunosorbent assay (ELISA). Body weight. Timepoint: Before the intervention - 8 weeks after the intervention. Method of measurement: Bio-Electrical Impedance Analysis (BIA). Fat mass. Timepoint: Before the intervention - 8 weeks after the intervention. Method of measurement: Bio-Electrical Impedance Analysis (BIA). Quality of life and treatment complications (diarrhea, nausea, constipation, vomiting and appetite). Timepoint: Before the intervention - 8 weeks after the intervention. Method of measurement: EORTC QLQ-C30 (The European Organization for Research and Treatment of Cancer quality of life questionnaire). Albumin and Total Protein. Timepoint: Before the intervention - 8 weeks after the intervention. Method of measurement: Autoanalyzer (spectrophotometric method). Complete Blood Count (CBC). Timepoint: Before the intervention - 8 weeks after the intervention. Method of measurement: cell counter. Tehran University of Medical Sciences Approved 2021-09-01 Ethics committee of Tehran University of Medical Sciences Faculty of Nutrition and Dietetics, University of Medical Sciences and Health Services, Tehran, Keshavarz Blvd., Naderi St., Hojjatdoost Alley, No. 44 Tehran Tehran Iran (Islamic Republic of)