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IRCT20230506058098N1 IRCT 2023-05-10 Esfahan University of Medical Sciences The effect of inulin on rheumatoid arthritis The effect of inulin supplementation on inflammation status, disease severity, and physical performance in patients with rheumatoid arthritis 2023-05-22 anticipated 60 Complete https://irct.ir/trial/69958 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Subjects will be allocated to receive the supplement or placebo using a block randomization method, 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: High-Performance Inulin (HPI) inulin supplement, with a degree of polymerization or DP higher than or equal to 22, under the brand name Frutafit® TEX, a product of Sensus/Netherlands, containing higher or equal to 99.5% of inulin and less than or equal to 0.5 The percentage composition of fructose, glucose, and sucrose is supplemented and prepared from Akbariye pharmaceutical importing company (Razavi Pharmaceutical Services Institute). The dosage is such that 1 capsule containing 10 grams of inulin is consumed daily for 60 days. inulin fructans; Oligo or polymer consists of D-fructose units with a glucose unit at the end. These compounds are found in foods such as celery, chicory, garlic, onions, wheat, bananas, soybeans, artichokes, and asparagus. Intervention 2: Control group: The placebo is prepared in bulk form from the domestic company "Golshehad Naqsh Jahan" and for the convenience of consumption, 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 30 and 65 years 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 30 years 65 years Both Pregnancy and breastfeeding smoking Following a special diet Taking drugs that affect the digestive microbiome, including antibiotics, proton pump inhibitors, and probiotic and prebiotic supplements in the last three months Inflammatory bowel diseases (Crohn's and ulcerative colitis) Using traditional medicine methods in the last 3 months Infectious rheumatoid arthritis M06.9 Rheumatoid arthritis, unspecified Treatment - Drugs Placebo High-Performance Inulin (HPI) inulin supplement, with a degree of polymerization or DP higher than or equal to 22, under the brand name Frutafit® TEX, a product of Sensus/Netherlands, containing higher or equal to 99.5% of inulin and less than or equal to 0.5 The percentage composition of fructose, glucose, and sucrose is supplemented and prepared from Akbariye pharmaceutical importing company (Razavi Pharmaceutical Services Institute). The dosage is such that 1 capsule containing 10 grams of inulin is consumed daily for 60 days. inulin fructans; Oligo or polymer consists of D-fructose units with a glucose unit at the end. These compounds are found in foods such as celery, chicory, garlic, onions, wheat, bananas, soybeans, artichokes, and asparagus. Control group: The placebo is prepared in bulk form from the domestic company "Golshehad Naqsh Jahan" and for the convenience of consumption, 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 Severity of rheumatoid arthritis. Timepoint: Measuring the severity of rheumatoid arthritis 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 tests and questionnaires related to the severity of rheumatoid arthritis. Esfahan University of Medical Sciences Approved 2023-01-24 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)