The Effect of a Plant-based Diet on the Active Rheumatoid Arthritis Activity.
NCT05911880 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28
Last updated 2023-08-31
Summary
The increase in autoimmune diseases in Western countries has been linked to environmental factors, and diet is considered a modifier of rheumatoid arthritis (RA). A high-fat diet promotes systemic inflammation and alters the microbiome. Certain bacteria in the intestinal microbiota generate proinflammatory metabolites from components of red meat, eggs, and dairy products. However, fruits and vegetables can modulate the gut microbiota and have been associated with reduced inflammation in RA patients. The aim of this study is to determine the changes in RA activity associated with plant-based dietary modifications. The study will evaluate men and women aged 18 years and older with low, moderate, or severe RA activity, and the intervention will involve an individualized, isocaloric plant-based diet for 14 days. The 28-joint disease activity score index and c-reactive protein (DAS 28-PCR) will be used to determine disease severity, in addition to analyzing the expression of inflammatory cytokines and microRNAs associated with RA.
Conditions
- Rheumatoid Arthritis
- Diet, Healthy
- Inflammatory Response
Interventions
- BEHAVIORAL
-
Plant-based diet for 14 days in patients with rheumatoid arthritis.
Patients with low to moderate disease activity of rheumatoid arthritis (2.6-5.1 DAS28-CRP) underwent a dietary intervention consisting of an individualized, isocaloric, and plant-based diet with 57% carbohydrates, 25% lipids, and 18% proteins (80% of plant origin) for 14 days, without any modification of their medication regimen and with restricted consumption of processed foods.
Sponsors & Collaborators
-
Instituto Nacional de Cardiologia Ignacio Chavez
lead OTHER
Principal Investigators
-
Fausto Sanchez, PhD · Instituto Nacional de Cardiología Ignacio Chávez
Study Design
- Allocation
- NA
- Purpose
- BASIC_SCIENCE
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-07-15
- Primary Completion
- 2024-07-15
- Completion
- 2024-12-15
Countries
- Mexico
Study Locations
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