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IRCT20230514058189N1 IRCT 2023-05-19 Ahvaz University of Medical Sciences Effects of flaxseed consumption in liver cirrhosis The effects of flaxseed powder consumption on disease severity, biochemical, inflammatory, anthropometric, sarcopenic parameters and quality of life in patients with liver cirrhosis. 2023-06-22 anticipated 50 Complete https://irct.ir/trial/70126 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this study, the block randomization method is used individually using sealedenvelope software. In order to hide the order of the codes, they are placed in closed envelopes so that the researcher does not know the order of the codes for the entry of people into the intervention or control group. N/A liver cirrhosis. Intervention 1: Intervention group: Patients in the intervention group will receive 30 grams of flaxseed powder daily for 12 weeks. Fresh flaxseed will be prepared and ground from Zarin giyahine store. 30 gram packages of flaxseed powder with the relevant packaging and label have been prepared and the consumption amount for one month will be provided to the patients. Patients are asked to consume one 30 gram packet every night with water, cold liquids or salad. Intervention 2: Control group: patients in the control group do not receive any food or placebo and the study is open labeled. 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 no more information
public Fatemeh Haidari
Jundishapour University of Medical Sciences- Golestan-Ahvaz
Ahvaz Iran (Islamic Republic of) 6135715794 0098 61 3311 Haidari58@gmail.com Ahvaz University of Medical Sciences scientific Fatemeh Haidari
Jundishapour University of Medical Sciences- Golestan- Ahvaz
Ahvaz Iran (Islamic Republic of) 6135715794 0098 61 3311 info@ajums.ac.ir Ahvaz University of Medical Sciences Iran (Islamic Republic of) All patients with liver cirrhosis whose cirrhosis has been confirmed by a specialist physician. 18 years 75 years Both Those who have other extrahepatic diseases at the same time. K74 Fibrosis and cirrhosis of liver Treatment - Other N/A Intervention group: Patients in the intervention group will receive 30 grams of flaxseed powder daily for 12 weeks. Fresh flaxseed will be prepared and ground from Zarin giyahine store. 30 gram packages of flaxseed powder with the relevant packaging and label have been prepared and the consumption amount for one month will be provided to the patients. Patients are asked to consume one 30 gram packet every night with water, cold liquids or salad. Control group: patients in the control group do not receive any food or placebo and the study is open labeled. Severity of liver cirrhosis according to Model for end stage liver disease score (MELD). Timepoint: Measurement of disease severity based on the MELD score before and 12 weeks after the start of flaxseed powder consumption. Method of measurement: Calculation of MELD using the formula and variables of bilirubin, creatinine and INR. Cirrhosis severity score based on child-Pugh. Timepoint: Measurement of mean cirrhosis severity based on child-Pugh score before and 12 weeks after flaxseed powder consumption. Method of measurement: child-Pugh calculation formula using the variables of bilirubin, albumin, INR (international normalized ratio), presence or absence of ascites and encephalopathy. Level of serum total cholesterol. Timepoint: Measurement of mean level of serum total cholesterol before and 12 weeks after flaxseed powder consumption. Method of measurement: Auto Analyzer and Total Cholesterol Test Kit (Biorex). Level of serum low density lipoprotein (LDL). Timepoint: Measurement of mean level of serum LDL before and 12 weeks after flaxseed powder consumption. Method of measurement: Auto Analyzer and LDL Test Kit (Biorex). Level of serum high density lipoprotein (HDL). Timepoint: Measurement of mean level of HDL before and 12 weeks after flaxseed powder consumption. Method of measurement: Auto Analyzer and HDL Test Kit (Biorex). Level of serum triglyceride (TG). Timepoint: Measurement of mean level of serum TG before and 12 weeks after flaxseed powder consumption. Method of measurement: Auto Analyzer and TG Test Kit (Biorex). Level of serum fasting blood sugar (FBS). Timepoint: Measurement of mean level of FBS before and 12 weeks after flaxseed powder consumption. Method of measurement: Auto Analyzer and FBS Test Kit (Biorex). Level of serum insulin. Timepoint: Measurement of mean level of serum insulin before and 12 weeks after flaxseed powder consumption. Method of measurement: Enzyme-linked immunosorbent double- antibody sandwich assay and insulin Test Kit (monobind). Homeostatic Model Assessment (HOMA-IR ) index. Timepoint: Measurement of HOMA-IR before and 12 weeks after flaxseed powder consumption. Method of measurement: HOMA-IR calculation formula. Quantitative insulin sensitivity check index (QUICKI). Timepoint: Measurement of QUICKI before and 12 weeks after flaxseed powder consumption. Method of measurement: QUICKI calculation formula. Level of serum total bilirubin. Timepoint: Measurement of mean level of serum total bilirubin before and 12 weeks after flaxseed powder consumption. Method of measurement: Auto Analyzer and total bilirubin Test Kit (Biorex). Level of serum albumin. Timepoint: Measurement of mean level of serum albumin before and 12 weeks after flaxseed powder consumption. Method of measurement: Auto Analyzer and albumin Test Kit (Biorex). Level of serum gamma-glutamyl transferase (GGT). Timepoint: Measurement of mean level of serum GGT before and 12 weeks after flaxseed powder consumption. Method of measurement: Auto Analyzer and GGT Test Kit (Biorex). Level of serum creatinine. Timepoint: Measurement of mean level of serum creatinine before and 12 weeks after flaxseed powder consumption. Method of measurement: Auto Analyzer and creatinine Test Kit (Biorex). Level of serum sodium. Timepoint: Measurement of mean level of serum sodium before and 12 weeks after flaxseed powder consumption. Method of measurement: standard solution Na. Prothrombin time (PT). Timepoint: Measurement of PT before and 12 weeks after flaxseed powder consumption. Method of measurement: manual. Partial prothrombin time (PTT). Timepoint: Measurement of PTT before and 12 weeks after flaxseed powder consumption. Method of measurement: manual. International normalized ratio (INR). Timepoint: Measurement of INR before and 12 weeks after flaxseed powder consumption. Method of measurement: Manual. Level of serum High-sensitivity C-reactive Protein (hs-CRP). Timepoint: Measurement of serum hs-CRP before and 12 weeks after flaxseed powder consumption. Method of measurement: Enzyme-linked immunosorbent double- antibody sandwich assay and hs-CRP Test Kit (Zelbio). Level of serum apelin. Timepoint: Measurement of serum apelin before and 12 weeks after flaxseed powder consumption. Method of measurement: Enzyme-linked immunosorbent double- antibody sandwich assay and apelin Test Kit (Zelbio). Body weight. Timepoint: Measurement of body weight mean before and 12 weeks after flaxseed powder consumption. Method of measurement: weight scale. Body mass index (BMI). Timepoint: Measurement of BMI mean before and 12 weeks after flaxseed powder consumption. Method of measurement: Calculation by formula. Lean body mass (LBM). Timepoint: Measurement of LBM mean before and 12 weeks after flaxseed powder consumption. Method of measurement: using of body analyzer (in body 270). Fat mass (FM). Timepoint: Measurement of FM mean before and 12 weeks after flaxseed powder consumption. Method of measurement: using of body analyzer (in body 270). Fat mass percent (FM%). Timepoint: Measurement of FM% mean before and 12 weeks after flaxseed powder consumption. Method of measurement: using of body analyzer (in body 270). Muscle strength. Timepoint: Measurement of muscle strength mean before and 12 weeks after flaxseed powder consumption. Method of measurement: using hand grip dynamometer (jamar hydraulic hand dynamometer B001D7QDJG). Muscle arm circumference (MAC). Timepoint: Measurement of MAC mean before and 12 weeks after flaxseed powder consumption. Method of measurement: using tape. Triceps skinfold thickness (TSF). Timepoint: Measurement of TSF mean before and 12 weeks after flaxseed powder consumption. Method of measurement: using caliper (Harpenden skinfold caliper FG1056). Frailty. Timepoint: Measurement of frailty mean before and 12 weeks after flaxseed powder consumption. Method of measurement: using liver frailty index (LFI) questionnaire. Sarcopenia. Timepoint: Measurement of sarcopenia mean before and 12 weeks after flaxseed powder consumption. Method of measurement: using Strength, assistance with walking, rising from a chair, climbing stairs, and falls questionnaire (SARC-F). Quality of life score. Timepoint: Measurement of mean quality of life score before and 12 weeks after flaxseed powder consumption. Method of measurement: using 36-Item Short Form Survey (SF-36) questionnaire. Mid arm muscle arm circumference (MAMC). Timepoint: Measurement of MAMC mean before and 12 weeks after flaxseed powder consumption. Method of measurement: Calculation by formula using muscle arm circumference (MAC) and triceps skinfold thickness (TSF). Ahvaz University of Medical Sciences Approved 2023-05-08 Ethics Committee of Ahvaz jundi shapour University of Medical Sciences jundishapour university of medical sciences, golestan, ahvaz Ahvaz Khouzestan Iran (Islamic Republic of)