Impact of a High-fiber Diet on the Microbiome and Disease Activity in Patients With Rheumatoid Arthritis

Condition(s) studied

Investigational drug(s) / intervention(s)

Psyllium husks: Patients 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.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Disease Activity Score 28 (DAS28) — Measurements will be assessed at baseline, 6 months, and 12 months.
  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 — Measurements will be assessed at baseline, 6 months, and 12 months.
  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 — Measurements will be assessed at baseline, 6 months, and 12 months.
  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 — Measurements will be assessed at baseline, 6 months, and 12 months.
  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.

Trial sites (1)

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