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IRCT20200429047235N2 IRCT 2024-01-06 Esfahan University of Medical Sciences The effect of astaxanthin on rheumatoid arthritis The effect of astaxanthin supplementation on antioxidant status, inflammation status, disease severity and physical performance in patients with rheumatoid arthritis 2023-12-22 anticipated 60 Complete https://irct.ir/trial/73979 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Patients stratified based on used drugs and BMI then randomly allocated into two groups using permuted random blocks of size 4, Blinding description: Placebo and supplement are completely similar in appearance and will be coded by someone other than the researcher so that the researcher is not involved in the grouping process. 3 Rheumatoid arthritis. Intervention 1: Intervention group: Astaxanthin is a natural carotenoid from the xanthophyll group, which exists in different amounts in different marine organisms such as algae, shrimp, crab, yeast, and salmon. Its main role is to create a desirable orange-red color in these organisms. Also, astaxanthin is a strong biological antioxidant and has the ability to inhibit free radicals. Individuals in the intervention group will receive a daily astaxanthin capsule made by the "Life Refreshing Biotechnology" company located in Al-Zahra University after lunch. By reviewing the relevant articles and the safe amount of astaxanthin consumption, the appropriate dose for astaxanthin supplement based on previous studies will be 20 mg per day in the form of oral capsules. Intervention 2: Control group: The placebo is prepared from Foodchem company and it is made in capsule form and distributed to the patients. The placebo is maltodextrin powder (corn starch) and is completely safe in terms of health. 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 Marzieh Kafeshani
Clinical nutrition Department, 1th Floor, Faculty of Nutrition and Food Sciences, Isfahan University of Medical science, Hezarjerib St
Esfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 3169 kafeshani_nut@yahoo.com Esfahan University of Medical Sciences scientific Marzieh Kafeshani
Clinical nutrition Department, 1th Floor, Faculty of Nutrition and Food Sciences, Isfahan University of Medical science, Hezarjerib St
Esfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 3169 kafeshani_nut@yahoo.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Age between 18 and 65 years Rheumatoid arthritis diagnosis by a specialist physician based on criteria (ACR) Having a disease activity score (DAS) higher than 3.2 Willingness to participate in the study and complete the consent form before starting the supplement therapy Not taking herbal and medicinal supplements, especially antioxidant supplements, in the three months before the start of the study Having a body mass index of 18.5 to 40 18 years 65 years Both Pregnancy and breastfeeding Smoking and being exposed to cigarette smoke on a daily basis Consumption of alcoholic beverages Following a special diet or exercise program Suffering from diseases such as diabetes mellitus, high blood pressure, thyroid disorder, kidney failure, liver dysfunction, Cushing's syndrome Inflammatory bowel diseases (Crohn's and ulcerative colitis) Using traditional medicine methods in the last 3 months Infectious rheumatoid arthritis Having a history of bariatric surgery Consumption of less than 80% of the total astaxanthin food supplement M06.9 Rheumatoid arthritis Treatment - Drugs Placebo Intervention group: Astaxanthin is a natural carotenoid from the xanthophyll group, which exists in different amounts in different marine organisms such as algae, shrimp, crab, yeast, and salmon. Its main role is to create a desirable orange-red color in these organisms. Also, astaxanthin is a strong biological antioxidant and has the ability to inhibit free radicals. Individuals in the intervention group will receive a daily astaxanthin capsule made by the "Life Refreshing Biotechnology" company located in Al-Zahra University after lunch. By reviewing the relevant articles and the safe amount of astaxanthin consumption, the appropriate dose for astaxanthin supplement based on previous studies will be 20 mg per day in the form of oral capsules. Control group: The placebo is prepared from Foodchem company and it is made in capsule form and distributed to the patients. The placebo is maltodextrin powder (corn starch) and is completely safe in terms of health. Antioxidant status. Timepoint: The patient's antioxidant status will be measured at the beginning of the study (before the start of the intervention) and 60 days after the start of the supplement (the end of the intervention). Method of measurement: Blood tests. Inflammation status. Timepoint: The measurement of inflammation will be done at the beginning of the study (before the intervention) and 60 days after the start of the supplement (the end of the intervention). Method of measurement: blood tests. Physical performance score. Timepoint: Physical performance will be measured at the beginning of the study (before the start of the intervention) and 60 days after the start of the supplement (the end of the intervention). Method of measurement: Disease activity score-28 will be used to measure the physical performance score. Illness severity. Timepoint: The severity of the disease will be measured at the beginning of the study (before the start of the intervention) and 60 days after the start of the supplement (the end of the intervention). Method of measurement: Visual Analogue Scale (VAS) will be used to measure the illness severity. Health evaluation. Timepoint: The patient's health will be evaluated at the beginning of the study (before the start of the intervention) and 60 days after the start of the supplement (the end of the intervention). Method of measurement: Health Assessment Questionnaire (HAQ) will be used to assess the patient's health. Grip strength. Timepoint: Muscle strength will be measured at the beginning of the study (before the start of the intervention) and 60 days after the start of the supplement (the end of the intervention). Method of measurement: Hand grip will be used to measure grip strength. C reactive protein (CRP). Timepoint: The serum level of C-reactive protein will be measured at the beginning of the study (before the start of the intervention) and 60 days after the start of the supplement (the end of the intervention). Method of measurement: Blood test. Red blood cell sedimentation rate. Timepoint: Red blood cell sedimentation rate will be measured at the beginning of the study (before the start of the intervention) and 60 days after the start of the supplement (the end of the intervention). Method of measurement: Blood test. Interleukin 6 serum level. Timepoint: Interleukin-6 serum levels will be measured at the beginning of the study (before the intervention) and 60 days after the start of the supplement (the end of the intervention). Method of measurement: Blood test. Malondialdehyde serum level. Timepoint: The measurement of serum malondialdehyde level will be done at the beginning of the study (before the start of the intervention) and 60 days after the start of taking the supplement (the end of the intervention). Method of measurement: Blood test. Total antioxidant capacity (TAC). Timepoint: Total antioxidant capacity will be measured at the beginning of the study (before the start of the intervention) and 60 days after the start of the supplement (the end of the intervention). Method of measurement: Blood test. Esfahan University of Medical Sciences Approved 2023-11-26 Ethics committee of Esfahan University of Medical Sciences Medical Ethics Department, 1st Floor, Building No. 3, School of Medicine, Isfahan University of Medical Sciences, Hezarjerib Street Esfahan Isfehan Iran (Islamic Republic of)