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IRCT20131125015536N15 IRCT 2024-07-24 Tehran University of Medical Sciences Effects of ketogenic diet in patients with endometriosis Investigating the effects of MCT-modified ketogenic diet on clinical symptoms, systemic inflammation and the expression of gene coding B-catenin in patients with endometriosis: A parallel randomized clinical trial 2024-11-20 anticipated 50 Complete https://irct.ir/trial/78113 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random allocation will be done by the Permuted Block Randomization method at the end of the Run-in period. In this method, eligible people who meet the criteria for entering the study are selected and then randomly assigned using 4 blocks based on the severity of endometriosis disease (first stage and second stage) in a random allocation method. They will be assigned to one of the two ketogenic and control diet groups. In random allocation, based on the list of random numbers, the letters A and B are assigned to the number equal to the random numbers. In this way, the letters A and B will be spread between the patient codes. Numbers will be assigned to patients according to the order of participants' entry, and patients will receive standard medical treatment (oral contraceptive pill) and ketogenic diet or standard medical treatment (oral contraceptive pill) based on specific letters (A and B). 2-3 Endometriosis. Intervention 1: Intervention group: In addition to the prescription of the standard drug regimen, i.e., oral contraceptive pills, the intervention of the ketogenic diet is explained to the patients of this group, and each patient is consulted by a nutritionist, and a ketogenic diet modified with MCT oil is written for them. Calories The diet is calculated based on the Meflin formula and based on the current weight. The designed diet consists of 70-80% fat, 15-20% protein, and 5-10% carbohydrates. The ratio of grams of fat and protein to carbohydrates is 3:1, and along with the diet, 500 cc of MCT oil was given to the patients every three weeks to accelerate the process of ketosis. Since MCT oil is tasteless, patients are advised to take 8 cc of oil (based on the amount written in the diet) after a main meal with a salad or on its own. About 40 food menus are written for patients to use any menu they like based on their personal preferences for 12 weeks. Intervention 2: Control group: Patients will be given a standard drug regimen (oral contraceptive pill) for 12 weeks. 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 There is no further information
public Mohammad Javad Hosseinzadeh Attar
Keshavarz Blvd.
Tehran Iran (Islamic Republic of) 1417613151 +98 21 8895 5742 Hosseinzadeh.md.phd@gmail.com Tehran University of Medical Sciences scientific Mohammad Javad Hosseinzadeh Attar
Keshavarz Blvd.
Tehran Iran (Islamic Republic of) 1417613151 +98 21 8895 5742 Hosseinzadeh.md.phd@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Age range between 25 and 35 years being married Diagnosis of endometriosis based on laparoscopic and pathological findings Having stage one or two endometriosis based on diagnostic laparoscopy or patients with a higher grade who underwent diagnostic-therapeutic laparoscopy and 3 months after laparoscopy, their disease stage was reduced to stage one or two Body mass index between 21 and 25 kg/m2 Having a VAS score of 3 out of 10 or greater than 3 out of 10 for pelvic pain and dyspareunia (pain during intercourse) and dyschezia (pain during defecation) 25 years 35 years Female Smoking and alcohol consumption Taking antidepressants for the past 6 months Pregnancy, breastfeeding and menopause Women who intend to become pregnant or take drugs such as clomifene, letrozole and gonadotropin Intestinal malabsorption (history of bariatric surgery, inflammatory bowel disease, celiac disease) Suffering from other diseases such as kidney disease and kidney stones, liver disorders and gallstones, cancer, heart diseases, acute and chronic infectious diseases, type 1 and 2 diabetes, Cushing's disease, acromegaly, and gigantism. Having myoma or polyps in the uterus N80.0 Endometriosis of uterus Treatment - Other Treatment - Drugs Intervention group: In addition to the prescription of the standard drug regimen, i.e., oral contraceptive pills, the intervention of the ketogenic diet is explained to the patients of this group, and each patient is consulted by a nutritionist, and a ketogenic diet modified with MCT oil is written for them. Calories The diet is calculated based on the Meflin formula and based on the current weight. The designed diet consists of 70-80% fat, 15-20% protein, and 5-10% carbohydrates. The ratio of grams of fat and protein to carbohydrates is 3:1, and along with the diet, 500 cc of MCT oil was given to the patients every three weeks to accelerate the process of ketosis. Since MCT oil is tasteless, patients are advised to take 8 cc of oil (based on the amount written in the diet) after a main meal with a salad or on its own. About 40 food menus are written for patients to use any menu they like based on their personal preferences for 12 weeks. Control group: Patients will be given a standard drug regimen (oral contraceptive pill) for 12 weeks. Expression of the gene coding beta-catenin protein. Timepoint: At the beginning of the study (before the start of the intervention) and at the end of the study (3 months after the intervention). Method of measurement: RT-PCR method. Score of clinical symptoms including pelvic pain, dyspareunia, and dyschezia. Timepoint: At the beginning of the study (before the start of the intervention) and at the end of the study (3 months after the intervention). Method of measurement: visual analog scale. Anthropometric measurements including weight, body mass index, waist circumference. Timepoint: At the beginning of the study (before the start of the intervention) and at the end of the study (3 months after the start of the intervention). Method of measurement: By a trained person using a scale and tape measure and calculating body mass index using the formula. Systemic inflammation indices including neutrophil-to-lymphocyte ratio, monocyte-to-lymphocyte ratio, platelet-to-lymphocyte ratio, and systemic inflammation response index. Timepoint: At the beginning of the study (before the start of the intervention) and at the end of the study (3 months after the start of the intervention). Method of measurement: Using the formula and data from the complete blood cell count test. Lipid profile including total cholesterol (TC), triglyceride (TG), high-density lipoprotein (HDL-C) and low-density lipoprotein (LDL-C). Timepoint: At the beginning of the study (before the start of the intervention) and at the end of the study (3 months after the start of the intervention). Method of measurement: Photometric method using laboratory kits. Liver enzymes (ALT and AST). Timepoint: At the beginning of the study (before the start of the intervention) and at the end of the study (3 months after the start of the intervention). Method of measurement: Enzymatic method using laboratory kits. Systolic and diastolic blood pressure. Timepoint: At the beginning of the study (before the start of the intervention) and at the end of the study (3 months after the start of the intervention). Method of measurement: Sphygmomanometer. Tehran University of Medical Sciences Approved 2024-07-12 Research ethics committee of school of medicine- Tehran university of medical sciences Keshavarz Blvd Tehran Tehran Iran (Islamic Republic of)