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IRCT20200304046692N1 IRCT 2020-03-11 Shiraz University of Medical Sciences Evaluating the effect of Spirulina in Non-alcoholic ّfatty liver patient. Evaluating the Effect of Spirulina Consumption on Anthropometric, Glucose, Lipid, Antioxidant, Inflammatory indices and Liver Enzymes in Non-Alcoholic ّFatty Liver Patient. 2019-12-11 anticipated 46 Complete https://irct.ir/trial/46330 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization of the two groups will be done by blocking method. The block size is set to 4 and all possible states for groups A and B are written and this is repeated until the number reaches 46. Then each component of the block is assigned a number using a random number table. The numbers given to each of the blocks represent the number assigned to each predefined number. This way the group assigned to each person is identified, Blinding description: The designed placebo is completely similar in color to that of the intervention group. To help the blind, the researcher is assisted by someone who is not involved in the research process. N/A Non-alcoholic fatty liver. Intervention 1: Intervention group: For 8 weeks, they will receive 2 grams of spirulina daily in form of the sauce prepared at the Shiraz Namakin Factory.Each 20g sauce sachet contains 2 grams of spirulina. At the beginning of the study, the number of sauces required will be delivered to each individual (30 sachets at the beginning of the first month and 30 sachets at the beginning of the second month). Individuals are asked to eat one sachet daily with food. Intervention 2: Control group: For 8 weeks, they will receive placebo daily in form of the sauce prepared at the Shiraz Namakin Factory with Edible color . At the beginning of the study, the number of sauces required will be delivered to each individual (30 sachets at the beginning of the first month and 30 sachets at the beginning of the second month). Individuals are asked to eat one sachet daily with food. Yes - There is a plan to make this available What will be shared: All potential data can be shared after unidentifiable people When: Start of the access period, 6 months after printing results To whom: For researchers working only in academic and scientific institutions Conditions: For use in research and publication of articles Where to obtain: Reza Barati 0098 9132807850 How to obtain: Initially contacting the researcher and expressing the request then reviewing the request by the researcher and finally sending the documentation if the researcher agrees Comments:
public Reza Barati
Khalili Blvd
Shiraz Iran (Islamic Republic of) 0 +98 71 3612 2206 reza93barati@gmail.com Shiraz University of Medical Sciences scientific Reza Barati
Khalili Blvd
Shiraz Iran (Islamic Republic of) 0 +98 71 3612 2206 reza93barati@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Individuals with Non-alcoholic fatty liver disease no limit no limit Both Individuals with malnutrition Individuals with alcohol consumption taking lipid-lowering drugs following special diets such as vegetarian or raw vegetarian diseases such as diabetes mellitus, cardiovascular disease, liver disease (cirrhosis, alcoholic liver disease, viral hepatitis, autoimmune hepatitis, primary biliary cirrhosis, biliary obstruction, hepatic injury induced by hereditary hemochromatosis drugs, sclerosis cholangitis, and α antisense deficiency), cancer, renal failure, celiac; being in pregnancy and lactation. taking Drugs that cause fatty liver (methotrexate, tamoxifen, valproate, etc.) K76.0 Fatty (change of) liver, not elsewhere classified Treatment - Other Placebo Intervention group: For 8 weeks, they will receive 2 grams of spirulina daily in form of the sauce prepared at the Shiraz Namakin Factory.Each 20g sauce sachet contains 2 grams of spirulina. At the beginning of the study, the number of sauces required will be delivered to each individual (30 sachets at the beginning of the first month and 30 sachets at the beginning of the second month). Individuals are asked to eat one sachet daily with food. Control group: For 8 weeks, they will receive placebo daily in form of the sauce prepared at the Shiraz Namakin Factory with Edible color . At the beginning of the study, the number of sauces required will be delivered to each individual (30 sachets at the beginning of the first month and 30 sachets at the beginning of the second month). Individuals are asked to eat one sachet daily with food. The degree of fatty liver. Timepoint: Before and after 8 weeks of intervention. Method of measurement: liver ultrasound. Anthropometric indices. Timepoint: Before and after 8 weeks of intervention. Method of measurement: Digital scales and tape meters. Lipid profile. Timepoint: Before and after 8 weeks of intervention. Method of measurement: Kit. Systolic and diastolic blood pressure. Timepoint: Before and after 8 weeks of intervention. Method of measurement: Mercury barometer. Blood sugar indices. Timepoint: Before and after 8 weeks of intervention. Method of measurement: Kit. Inflammatory indices. Timepoint: Before and after 8 weeks of intervention. Method of measurement: enzyme-linked immunosorbent assay( ELISA)kit. Liver enzymes. Timepoint: Before and after 8 weeks of intervention. Method of measurement: Kit. Shiraz University of Medical Sciences Approved 2020-01-13 Ethics committee of Baqyatallah University of Medical Sciences Mulla Sadra Street, Vanak Square, Tehran Tehran Tehran Iran (Islamic Republic of)