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IRCT20100209003320N23 IRCT 2024-01-30 Tabriz University of Medical Sciences The effect of chia seeds on non-alcoholic fatty liver disease Evaluation of the effects of Chia seeds (Salvia hispanica) on nutritional status, metabolic factors, liver function, inflammatory hematologic and atherogenic indices in obese patients with non-alcoholic fatty liver disease 2024-02-20 anticipated 38 Complete https://irct.ir/trial/74195 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: A research assistant not otherwise involved in the study, will randomly allocate 38 patients into one of the two experimental groups (1:1), using the Random allocation software (RAS) and randomized block procedure (age (18-39 vs 39-60 years)- gender (female vs male) and BMI (<35 kg/m2 vs. ≥35 kg/m2)), Blinding description: A research assistant not otherwise involved in the study, randomly allocated the participants into one of the two experimental groups (1:1), using the Random allocation software (RAS) and randomized block procedure. The person (completely unrelated to the study) who will prepare the supplement sachets will assigne a 3-digit code for each treatment. 3 Non-alcoholic fatty liver disease. Intervention 1: "Intervention group": patients in this group will receive chia seeds along with a weight loss diet, taking into account that 100 grams of chia seeds contain 486 calories (approximately 200 calories for 40 grams of chia seeds per day) to moderate the amount of weight loss Calories in the intervention group will be reduced by 700 kilocalories and to adjust the diet with the distribution of macronutrients as 55% carbohydrates, 30% fat, 15% protein. Daily, two 20-gram sachets of Paraguayan chia seeds will be purchased from Isfahan Herbal Company in sachet form. 20 grams will be packed, half an hour before two meals a day, and they will be consumed in a glass of lukewarm water. The duration of the study will be 8 weeks. People in the intervention group will be asked to bring unused sachets with them every two weeks to determine compliance. Weight control and distribution of sachets will be done every two weeks. Intervention 2: "Control group": patients in this group will only receive a weight loss diet (500 kcal reduction) along with a glass of water before two main meals for 8 weeks. Yes - There is a plan to make this available What will be shared: Data collected for the primary outcomes will be shared When: The access period starts 12 months after the results are published To whom: The data will be available only to people working in scientific institutions Conditions: The data of this study will be available to other researchers only for meta-analysis studies Where to obtain: Maryam Parimi, email address: maryam.parimi6@gmail.com, phone number: 09109337321 How to obtain: The applicant should provide a brief explanation of the goals and methodology of his meta-analysis. The applicant's request will be reviewed and if approved, the data will be sent to the applicant via email. All these steps will not take more than 15 days Comments:
public Dr. Mehrangiz Ebrahimi- Mameghani
Faculty of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Attar Neishaburi St, Golgasht St.
Tabriz Iran (Islamic Republic of) 5166614711 +98 41 3335 7584 ebrahimimamagani@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Dr. Mehrangiz Ebrahimi- Mameghani
Faculty of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Attar Neishaburi St, Golgasht St.
Tabriz Iran (Islamic Republic of) 5185747731 +98 41 3335 7584 ebrahimimamagani@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Both genders Age range of 18 to 60 years body mass index= 30- 39.9 Kg/m2 Hepatic steatosis based on ultrasound findings (grade 1 and 2) willingness to participate in the study 18 years 60 years Both Athletes pregnancy breastfeeding menopause Under infertility treatment taking birth control pills estrogen therapy Smoking history of alcohol consumption Taking medications including chemical or herbal medications for weight loss anti-hypertensive Fat-lowering drugs Sugar-lowering drugs any nutritional supplements from 3 months before the study Having cardiovascular diseases Liver dysfunction Kidney dysfunction Intestinal dysfunction Thyroid dysfunction Parathyroid dysfunction known autoimmune diseases polycystic ovary syndrome cancers Following a special diet in the last three months performing weight loss surgery in the last one year Taking Phenytoin medicine Taking amoxifene medicine Taking lithium medicine Performing or being a candidate for liver transplantation K76.0 Fatty (change of) liver, not elsewhere classified Treatment - Drugs Lifestyle "Intervention group": patients in this group will receive chia seeds along with a weight loss diet, taking into account that 100 grams of chia seeds contain 486 calories (approximately 200 calories for 40 grams of chia seeds per day) to moderate the amount of weight loss Calories in the intervention group will be reduced by 700 kilocalories and to adjust the diet with the distribution of macronutrients as 55% carbohydrates, 30% fat, 15% protein. Daily, two 20-gram sachets of Paraguayan chia seeds will be purchased from Isfahan Herbal Company in sachet form. 20 grams will be packed, half an hour before two meals a day, and they will be consumed in a glass of lukewarm water. The duration of the study will be 8 weeks. People in the intervention group will be asked to bring unused sachets with them every two weeks to determine compliance. Weight control and distribution of sachets will be done every two weeks "Control group": patients in this group will only receive a weight loss diet (500 kcal reduction) along with a glass of water before two main meals for 8 weeks. Insulin. Timepoint: Baseline and after 8 weeks. Method of measurement: ELISA method. Hemoglobin A1C. Timepoint: Baseline and after 8 weeks. Method of measurement: chromatography. Total cholesterol. Timepoint: Baseline and after 8 weeks. Method of measurement: Enzymatic method. Triglyceride. Timepoint: Baseline and after 8 weeks. Method of measurement: Enzymatic method. HDL cholesterol. Timepoint: Baseline and after 8 weeks. Method of measurement: Enzymatic-colorimetric method using spectrophotometer. LDL cholesterol. Timepoint: Baseline and after 8 weeks. Method of measurement: Based on the ّFriedelwald formula. Insulin resistance indices (HOMA-IR, HOMA-B and QUICKI). Timepoint: Baseline and after 8 weeks. Method of measurement: Based on the formula. Body mass index(BMI). Timepoint: Baseline and after 8 weeks. Method of measurement: Based on the formula. Waist circumference. Timepoint: Baseline and after 8 weeks. Method of measurement: tape measure. Waist to hips ratio (WHR). Timepoint: Baseline and after 8 weeks. Method of measurement: Based on the formula. Waist to Height ratio (WHTR). Timepoint: Baseline and after 8 weeks. Method of measurement: Based on the formula. Fat mass. Timepoint: Baseline and after 8 weeks. Method of measurement: Body analyzer. Fat Free mass. Timepoint: Baseline and after 8 weeks. Method of measurement: Body analyzer. Energy, macronutrients and micronutrients intake. Timepoint: Baseline and after 8 weeks. Method of measurement: 24- hr food recall questionnaire for 3 days and Nutritionist 4 software. Physical activity level. Timepoint: Baseline and after 8 weeks. Method of measurement: IPAQ Questionnaire- short form. Appetite status. Timepoint: Baseline and after 8 weeks. Method of measurement: Validated appetite questionnaire. Body weight. Timepoint: Baseline and after 8 weeks. Method of measurement: Scale. Fasting glucose. Timepoint: Baseline and after 8 weeks. Method of measurement: Enzymatic method. Complete blood cell count (CBC). Timepoint: Baseline and after 8 weeks. Method of measurement: Coulter counter. Serum Albumin. Timepoint: Baseline and after 8 weeks. Method of measurement: using BROMOCRESOL GREEN. Platelets count. Timepoint: Baseline and after 8 weeks. Method of measurement: Coulter counter. Liver fibrosis score. Timepoint: Baseline and after 8 weeks. Method of measurement: based on formula. Total body water. Timepoint: Baseline and after 8 weeks. Method of measurement: Using bioelectric impedance analyzer. Hematological indicators of inflammation (the number of monocytes, neutrophils, lymphocytes and platelets in whole blood and the estimation of the ratios of monocytes, neutrophils and platelets to lymphocytes). Timepoint: Baseline and after 8 weeks. Method of measurement: Coulter counter. Atherogenic indices (LDL-C/HDL-C, TC/HLD-C, TG/HDL-C, nonHDL-C/HDL-C). Timepoint: Baseline and after 8 weeks. Method of measurement: Based on the formula. Hip circumference. Timepoint: Baseline and after 8 weeks. Method of measurement: tape measure. Serum ferritin. Timepoint: Baseline and after 8 weeks. Method of measurement: Electrochemiluminescence method. Fatty liver grade. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Ultrasonigraphy findings. Alanine aminotransferase (ALT). Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Enzymatic method. Aspartate aminotransferase (AST). Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Enzymatic method. Tabriz University of Medical Sciences Approved 2024-01-01 Ethics Committee of Tabriz University of Medical Sciences Faculty of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Attar Neishaburi St, Golgasht St. Tabriz East Azarbaijan Iran (Islamic Republic of)