The Effect of a Plant-based Diet on the Active Rheumatoid Arthritis Activity.

NCT05911880 | Unknown

• 1 other identifier: 211247
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

vegetarian diet; cytokine; Arthritis; DAS-28; anti-inflammatory diet; pain

Outcome Measures

Primary Outcomes (1)

• Change from baseline in disease activity by DAS28 at 14 days after with a plant-based diet

  Is a scoring system to evaluate disease activity and treatment response in rheumatoid arthritis (RA). The scores are divided as follows: 0-2.5: Remission 2.6-3.2: Low activity 3.3-5.1: Moderate activity \>5.1: high activity This evaluates the joint count of 28 painful and inflamed joints in conjunction with the value of C-reactive protein (mg/L).

  14 days

Secondary Outcomes (13)

• Change from baseline in C-Reactive Protein (CRP) by automated photometry at 14 days after with a plant-based diet

  14 days

• Change from baseline in Erythrocyte Sedimentation Rate (ESR) by automated photometry at 14 days after with a plant-based diet

  14 days

• Change from baseline in glucose by automated photometry at 14 days after with a plant-based diet

  14 days

• Change from baseline in Uric acid automated photometry at 14 days after with a plant-based diet

  14 days

• Change from baseline in total cholesterol concentration by automated photometry at 14 days after with a plant-based diet

  14 days

Study Arms (1)

Subjets with rheumatoid arthritis treated with a plant-based diet for 14 days

EXPERIMENTAL

The present study focuses on a dietary intervention in human subjects who have been diagnosed with rheumatoid arthritis for at least one year. The intervention consists of an individualized nutritional plan, isocaloric, and modifies the percentage of plant-based proteins to 80%, for 14 days, to evaluate if a plant-based diet affects the disease activity. The calorie intake given to each subject is calculated based on the average of 3 24-hour recalls and the basal energy expenditure using the Harris \& Benedict formula. No medication modifications are made three months before and during the intervention. Fasting blood samples of blood are collected via venipuncture before and after the intervention to analyze the blood chemistry of six elements, a complete blood count, as well as to analyze the expression of microRNAs related to the disease and pro-inflammatory cytokines. In addition, body measurements (weight, body fat, visceral fat, and muscle) are taken using bioimpedance.

Behavioral: Plant-based diet for 14 days in patients with rheumatoid arthritis.

Interventions

Plant-based diet for 14 days in patients with rheumatoid arthritis. BEHAVIORAL

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.

Also known as: Mediterranean diet, vegetarian diet, vegan diet, lacto-vegetarian diet, lacto-ovo-vegetarian diet

Subjets with rheumatoid arthritis treated with a plant-based diet for 14 days

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects over 18 years of age.
• Established diagnosis of rheumatoid arthritis according to American College Rheumatoid (ACR) 1987 or ACR/European Alliance of Associations for Rheumatology (EULAR) 2010 criteria.
• Disease activity according to DAS 28 (defined as all \> 2.6).

You may not qualify if:

• Systemic autoimmune superposition syndrome (with the exception of: fibromyalgia, thyroid pathology, Type 1 Diabetes Mellitus, syndrome Sjögren and antiphospholipid syndrome)
• Patients on treatment with coumarins
• Patients with cancer, chronic hepatitis, HIV, pregnancy
• Weight variations associated with diet in last 6 months

Sponsors & Collaborators

• Instituto Nacional de Cardiologia Ignacio Chavez: lead

Study Sites (1)

Instituto Nacional de Cardiología "Ignacio Chávez"

Mexico City, Tlalpan, 14000, Mexico

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid; Arthritis; Pain

Interventions

Diet, Plant-Based; Diet, Mediterranean; Diet, Vegetarian; Diet, Vegan

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Fausto Sanchez, PhD

  Instituto Nacional de Cardiología Ignacio Chávez

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fausto Sanchez, PhD

CONTACT

5555732911; fausto22@yahoo.com

Mario Pena, B. Sc

CONTACT

5555732911; marionutricion2017@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher in Medical Sciences D

Model Details: Patients with established diagnosis of Rheumatoid Arthritis by the ACR 1987 or ACR/EULAR 2010 criteria, with mild to moderate disease activity measured by DAS-28 PCR (2.6-5.1), with personalized nutritional intervention, isocaloric and with modification of the percentage of proteins from plant origin (80%), for 14 days.

Study Record Dates

• First Submitted: March 4, 2023
• First Posted: June 22, 2023
• Study Start: July 15, 2021
• Primary Completion: July 15, 2024
• Study Completion: December 15, 2024
• Last Updated: August 31, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)