The effect of probiotic supplementation on lipid profile and arylesterase activity of paraoxonase enzyme in women with rheumatoid arthritis

Phase 2

• Conditions: Rheumatoid arthritis.; Rheumatoid arthritis, unspecified

• Registration Number: IRCT201306264105N14
• Lead Sponsor: Research Vice chancellor, Tabriz University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

patients diagnosed with rheumatoid arthritis, based on ACR criteria; having inactive to moderate rheumatoid arthritis; under treatment with DMARDs (Methotrexate, Hydroxychloroquine and Prednisolone less than 10 milligrams per day) and not receiving NSAIDs or cytokine inhibitors; stable medication for at least 3 month prior to the interventions; having body mass index (BMI) less than 40; willing to participate in the study; ages between 20 and 80. Exclusion criteria: pregnant and lactating women; hormone therapy or receiving oral contraceptives; having diabetes mellitus, thyroid disorders, kidney or hepatic diseases or Cushing's syndrome; having inflammatory bowel disease or other inflammatory disorders; having digestive tract disorders or lactose intolerance; Taking antioxidant, vitamin, fiber or omega-3 supplements 3 weeks prior to the interventions; using antibiotics a month prior to the interventions; being on a weight reduction diet; smoking or being exposed to cigarette smoke; using other probiotic products.

Exclusion Criteria

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Triglyceride. Timepoint: At baseline and after 8 weeks of intervention. Method of measurement: Spectrophotometry.;Total cholesterol. Timepoint: At baseline and after 8 weeks of intervention. Method of measurement: Spectrophotometry.;HDL cholesterol. Timepoint: At baseline and after 8 weeks of intervention. Method of measurement: Spectrophotometry.;LDL cholesterol. Timepoint: At baseline and after 8 weeks of intervention. Method of measurement: Friedewald equation.;Arylesterase activity of paraoxonase enzyme. Timepoint: At baseline and after 8 weeks of intervention. Method of measurement: Spectrophotometry.