The goal of this clinical trial is to learn if increasing dietary fiber can improve the gut microbiome and reduce disease activity in adults with rheumatoid arthritis (RA). The main questions it aims to answer are:
* Can a higher fiber diet improve gut bacteria and produce beneficial short-chain fatty acids (SCFAs)? * Does a higher fiber diet reduce RA symptoms and help with weight loss?
Researchers will compare two groups: one group will receive dietary counseling and take 10 grams of psyllium husk daily, while the other group will continue their usual diet.
Participants will:
* Complete dietary questionnaires at the start, 6 months, and 12 months. * Provide stool samples for gut bacteria and SCFA analysis. * Have their RA activity and body weight monitored regularly. * Receive regular phone calls to support the dietary changes.
The study will involve adults with diagnosed RA who can provide informed consent and meet other inclusion criteria.
Patients over 18 years old
Diagnosis of Rheumatoid Arthritis according to the ACR criteria of 2010
The patient can understand the scope of the study and consents in writing to participate.
Age under 18
Lack of consent capability
Insufficient knowledge of the German language
Chronic inflammatory bowel disease
Parallel
Psyllium husks
Other interventionPatients in the intervention group will receive nutritional counseling and will be asked to take 10g (one tablespoon) of ground psyllium husks daily to significantly increase the fiber content of their diet.
Disease Activity Score 28 (DAS28)
The Disease Activity Score 28 (DAS28) is a composite measure used to assess the activity of rheumatoid arthritis (RA). It is calculated using the number of tender and swollen joints (out of 28 specified joints) and the patient's global health assessment. The DAS28 score ranges from 0 to 9.4, with higher scores indicating higher disease activity. This measure is widely used in clinical practice and research to monitor and evaluate the effectiveness of RA treatments.
C-Reactive Protein (CRP) Level
C-reactive protein (CRP) level is a biomarker used to measure inflammation in the body. Elevated CRP levels are indicative of inflammation and are commonly seen in rheumatoid arthritis patients. CRP levels will be measured using blood tests to assess the inflammatory status of the participants.
Short-Chain Fatty Acids (SCFA) Levels in Stool
The concentration of short-chain fatty acids (SCFAs) in stool samples will be measured. SCFAs, such as acetate, propionate, and butyrate, are produced by the gut microbiota through the fermentation of dietary fibers. These compounds play a crucial role in maintaining gut health and modulating the immune system. The levels of SCFAs will be analyzed to determine the impact of increased dietary fiber intake on gut microbiota composition and function.
Body Weight
Participants' body weight will be measured to assess changes over the study period. Weight measurements will be taken using a standardized and calibrated scale. Changes in body weight will help determine the effect of increased dietary fiber intake on weight management in individuals with rheumatoid arthritis.
Patient Global Assessment of Disease Activity
The Patient Global Assessment of Disease Activity is a subjective measure where participants rate their overall disease activity on a scale from 0 (no disease activity) to 10 (maximum disease activity). This assessment provides insight into the patient's perception of their rheumatoid arthritis and its impact on their daily life.
Health Assessment Questionnaire-Disability Index (HAQ-DI)
The Health Assessment Questionnaire-Disability Index (HAQ-DI) is a self-reported questionnaire used to assess the degree of difficulty a person has in performing daily activities due to their rheumatoid arthritis. The HAQ-DI scores range from 0 (no disability) to 3 (severe disability).
Erythrocyte Sedimentation Rate (ESR)
The Erythrocyte Sedimentation Rate (ESR) is a blood test that measures how quickly erythrocytes (red blood cells) settle at the bottom of a test tube. A faster-than-normal rate may indicate inflammation in the body, which is common in rheumatoid arthritis. ESR levels will be measured to evaluate the inflammatory status of the participants.
Changes in Gut Microbiome Composition
The composition of the gut microbiome will be analyzed using stool samples. This analysis will focus on identifying the types and quantities of bacteria present in the gut. Changes in microbiome composition will be assessed to understand the impact of increased dietary fiber intake on gut health and its potential relationship with rheumatoid arthritis.
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Wuerzburg University Hospital
Lead sponsor
RheinNatur Food GmbH
Collaborator
