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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

ABSTRACT: 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. Primary outcome(s): 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-a). Timepoint: Before the intervention - 8 weeks after the intervention. Method of measurement: enzyme-linked immunosorbent assay (ELISA). Study Design: 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.

DISEASE(S): Colorectal Cancer Cachexia,Cachexia

PROVIDER: 2504740 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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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

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