Trials · 2024
The effects of intermittent fasting diet on quality of life, clinical symptoms, inflammation, and oxidative stress in overweight and obese postmenopausal women with rheumatoid arthritis: study protocol of a randomized controlled trial.
Протокол клинического исследованияСтатьяНазвание и аннотация: Перевод в очереди
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Ranjbar Mahsa, Shab-Bidar Sakineh, Rostamian Abdolrahman, Mohammadi Hamed, Djafarian Kurosh
Аннотация
BACKGROUND: Rheumatoid arthritis (RA) is known as a chronic systemic autoimmune disorder that primarily targets synovial joints, and may cause pain and functional limitations. Studies show diet can have beneficial effects on symptoms and oxidative stress of this disease. Intermittent fasting (IF) is a dietary approach with cycles of fasting and intake. The current study aims to investigate the effect of IF on quality of life, clinical symptoms, inflammation, and oxidative stress in overweight and obese postmenopausal women with RA.
METHODS: The current study is a randomized clinical trial, in which 44 patients with mild to moderate severity of RA will be randomly allocated to receive either IF (n = 22) or the usual diet (n = 22) for 8 weeks. Anthropometric measures and biochemical indicators including serum concentrations of erythrocyte sedimentation rate (ESR), c-reactive protein (CRP), and total oxidant and antioxidant capacity (TOC and TAC) will be assessed at the baseline and end of the study. Also, disease severity will be assessed by Disease Activity Score-28 (DAS-28) and clinical disease activity index (CDAI), and disability index will be assessed by Health Assessment Questionnaire-Disability Index (HAQ-DI) questionnaire.
DISCUSSION: Studies show fasting has beneficial effects on inflammatory markers and results in an improvement in the health of different populations. Literature review shows it seems there is no study in this field to evaluate the effects of IF on RA patients, and they are limited to other types of fasting. However, studies show IF can have many positive effects on chronic and autoimmune diseases. Therefore, IF may have positive effects on these patients.
TRIAL REGISTRATION: IRCT20230217057441N1. Registered on 14 February 2023. https://en.irct.ir/user/trial/68669 .
METHODS: The current study is a randomized clinical trial, in which 44 patients with mild to moderate severity of RA will be randomly allocated to receive either IF (n = 22) or the usual diet (n = 22) for 8 weeks. Anthropometric measures and biochemical indicators including serum concentrations of erythrocyte sedimentation rate (ESR), c-reactive protein (CRP), and total oxidant and antioxidant capacity (TOC and TAC) will be assessed at the baseline and end of the study. Also, disease severity will be assessed by Disease Activity Score-28 (DAS-28) and clinical disease activity index (CDAI), and disability index will be assessed by Health Assessment Questionnaire-Disability Index (HAQ-DI) questionnaire.
DISCUSSION: Studies show fasting has beneficial effects on inflammatory markers and results in an improvement in the health of different populations. Literature review shows it seems there is no study in this field to evaluate the effects of IF on RA patients, and they are limited to other types of fasting. However, studies show IF can have many positive effects on chronic and autoimmune diseases. Therefore, IF may have positive effects on these patients.
TRIAL REGISTRATION: IRCT20230217057441N1. Registered on 14 February 2023. https://en.irct.ir/user/trial/68669 .