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IRCT20110510006431N5 IRCT 2022-09-14 Shahid Beheshti University of Medical Sciences effect of Spirulina in nonalcoholic fatty liver disease The effect of Spirulina supplementation on anthropometric index, blood glucose, lipid profile, liver enzymes and cardiometabolic risk factors in nonalcoholic fatty liver disease patients: A randomized double-blinded clinical trial 2022-09-23 anticipated 50 Complete https://irct.ir/trial/65320 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, patients are divided into 2 intervention groups: intervention (as Spirulina supplement group) and control group (as placebo group) (named groups A and B), to randomly assign patients to two groups of methods. Stratified blocked randomization is used. The division of branches is based on gender, so patients are first classified into two groups based on gender: male and female (as 2 to Strata). After specifying the quadruple blocks in different arrangements (AABB, ABAB, ABBA, etc.), the lottery method with placement is used to determine the treatment allocation list. It is also necessary to explain that in order to observe the concealment in the mentioned plan, the randomization operation is performed by a person other than the main researcher, and the codes specified in the packets in the package after randomization are provided to the researchers for random sampling and assignment. Placed in the intervention or control group, Blinding description: The study is double-blind. A person other than the researcher who has no information about how to perform and the purpose of the study will use a list of random numbers to encode the Spirulina supplement and placebo and will be numbered according to the list so that the researcher does not know The type of supplements should be observed by each group. Participants will also have no information about the contents of the package. N/A Nonalcoholic Fatty Liver Disease. Intervention 1: Intervention group: for 12 weeks, 3-gram Spirulina per day from the Drotat high-tech and pharmaceutical science company in Iran. Intervention 2: Control group: for 12 weeks, 3-gram maltodextrin per day from the Drotat high-tech and pharmaceutical science company in Iran. 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 Because the participant’s informations should remain confidental.
public Mahdi Shadnoush
Hafezi Ave, Shahid Farahzadi Blvd, Shahrak Qarb
Tehran Iran (Islamic Republic of) 1985717443 +98 21 2237 6480 mshadnoush@gmail.com Shahid Beheshti University of Medical Sciences scientific Mahdi Shadnoush
Hafezi Ave, Shahid Farahzadi Blvd, Shahrak Qarb
Tehran Iran (Islamic Republic of) 1985717443 +98 21 2237 6480 mshadnoush@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Age ≥18 years old, AST > 38, ALT > 40, Steatohepatitis grade 1,2 or 3 according to Ultrasound report, Having a history of alcohol consumption of less than 10 gram per day in women and less than 20 gram per day in men, Absence of other acute and chronic diseases and liver disorders (hepatitis B, C, etc.), biliary disease, known autoimmune diseases, cancer and inherited disorders affecting liver condition (storage disease of iron, and copper. ..), Hypertension, cardiovascular diseases, lung disease and kidney disease, cirrhosis, and celiac disease, Absence of pregnancy or lactation, Athletes or hospitalization, No consumption medications such as metformin, vitamin E and Ursodeoxycholic Acid (UDCA), No consumption hepatotoxic drugs such as phenytoin, tamoxifen and lithium, and corticosteroids and methotrexate, No consumption medications or antibiotics over a week during the study period or before entering it, No history of weight loss surgery in during year during, weight loss program during past 3-month, No history of hypothyroidism, Cushing's syndrome, and diabetes, Lack of gall bladder disease 18 years 75 years Both K75.8 Other specified inflammatory liver diseases Treatment - Other Treatment - Other Intervention group: for 12 weeks, 3-gram Spirulina per day from the Drotat high-tech and pharmaceutical science company in Iran. Control group: for 12 weeks, 3-gram maltodextrin per day from the Drotat high-tech and pharmaceutical science company in Iran. LDL-C. Timepoint: Beginning and end of the study. Method of measurement: Enzymatic method using a kit. HDL-C. Timepoint: Beginning and end of the study. Method of measurement: Enzymatic method using a kit. TG. Timepoint: Beginning and end of the study. Method of measurement: Enzymatic method using a kit. Total Cholestrol. Timepoint: Beginning and end of the study. Method of measurement: Enzymatic method using a kit. AST. Timepoint: Beginning and end of the study. Method of measurement: Enzymatic method using a kit. ALT. Timepoint: Beginning and end of the study. Method of measurement: Enzymatic method using a kit. Hepatic Steatosis. Timepoint: Beginning and end of the study. Method of measurement: Ultrasound. Hs-CRP. Timepoint: Beginning and end of the study. Method of measurement: ELISA. GSH. Timepoint: Beginning and end of the study. Method of measurement: ELISA. Total antioxidant capacity. Timepoint: Beginning and end of the study. Method of measurement: ELISA. FBS. Timepoint: Beginning and end of the study. Method of measurement: Enzymatic method using a kit. HOMA-IR. Timepoint: Beginning and end of the study. Method of measurement: Calculation. Weight. Timepoint: Beginning and end of the study. Method of measurement: Balance. Body mass index. Timepoint: Begining and end of the study. Method of measurement: Calculation. Leptin. Timepoint: Beginning and end of the study. Method of measurement: ELISA. Lipopolysaccharides. Timepoint: Beginning and end of the study. Method of measurement: ELISA. Waist circumstance. Timepoint: Beginning and end of the study. Method of measurement: tape. Total Calorie Intake. Timepoint: Beginning and end of the study. Method of measurement: 3- days Recall Questionnaire. Total Carbohydrate Intake. Timepoint: Beginning and end of the study. Method of measurement: 3- days Recall Questionnaire. Total Protein Intake. Timepoint: Beginning and end of the study. Method of measurement: 3- days Recall Questionnaire. Total Fat Intake. Timepoint: Beginning and end of the study. Method of measurement: 3- days Recall Questionnaire. Total Fiber Intake. Timepoint: Beginning and end of the study. Method of measurement: 3- days Recall Questionnaire. Total MUFA Intake. Timepoint: Beginning and end of the study. Method of measurement: 3- days Recall Questionnaire. Total PUFA Intake. Timepoint: Beginning and end of the study. Method of measurement: 3- days Recall Questionnaire. Total SFA Intake. Timepoint: Beginning and end of the study. Method of measurement: 3- days Recall Questionnaire. Shahid Beheshti University of Medical Sciences Approved 2022-05-28 Ethics committee of Shahid Beheshti University of Medical Sciences Arabi Ave, Daneshjoo Blvd, Velenjak Tehran Tehran Iran (Islamic Republic of)