A study on the effect of chia seed intake inflammatory markers, joint pain severity, body weight and quality of life in patients with rheumatoid arthritis

Effect of chia seed intake on RF, CRP, ESR; inflammatory CBC indices; Anti-CCP; joint pain (VAS); disease activity (DAS28); body weight and BMI; quality of life (SF-36).

A randomized controlled clinical trial with two parallel groups, single-blinded with blinding of the principal investigator and outcome assessor, will be conducted over 8 weeks in 22 patients with rheumatoid arthritis; participants will be allocated using simple randomization and a computer-generated random number table.

8-week randomized controlled, two-group, single-blind trial in rheumatoid arthritis patients at Urmia University of Medical Sciences rheumatology clinics. After informed consent, eligible patients will be randomized to chia seeds (30 g/day) or usual diet. Inflammatory markers, pain, disease activity, weight, and quality of life will be assessed at baseline and study end. Allocation and intervention distribution will be performed independently; the principal investigator and outcome assessor will be blinded.

**Inclusion:** Confirmed RA; age 18–70 years; disease duration ≥6 months; informed consent; ability to cooperate. **Exclusion:** Inflammatory, autoimmune, infectious diseases, or cancer; omega-3 supplements, anti-inflammatory products, or herbal medicines; changes in arthritis medication; severe flare; chia allergy; pregnancy/breastfeeding.

Intervention group: 30 g/day chia seeds for 8 weeks, fully soaked and consumed with yogurt, salad, or smoothie, while continuing the usual diet. Control group: No chia seeds for 8 weeks; usual diet continued.

RF; CRP; ESR; Anti-CCP; CBC inflammatory indices; pain severity (VAS); disease activity (DAS28); body weight and BMI; quality of life (SF-36)

Patients with rheumatoid arthritis will be randomly allocated to two groups: an intervention group and a control group. Participants will be assigned to the groups using a computer-generated random number table and simple randomization.

Participants will be randomly allocated to two groups, an intervention group and a control group, using simple randomization. The group allocation and distribution of chia seeds will be carried out by an individual independent of the principal investigator. Based on the randomization list, this individual will provide chia seeds to participants allocated to the intervention group, while no intervention will be provided to participants in the control group. To maintain blinding, the principal investigator will not have access to the group allocation and will not be informed of which group each participant has been assigned to. In addition, the outcome assessor, who will be responsible for conducting clinical assessments and measuring the study variables, will remain unaware of the participants’ group assignments. Weekly follow-up and assessment of adherence to the intervention will also be conducted by the independent individual to ensure that neither the principal investigator nor the outcome assessor becomes aware of the participants’ group assignments throughout the study. The group allocation codes will be kept by the independent individual until completion of the outcome assessments and will be decoded, if necessary, after the final assessments have been completed. Accordingly, participants and the intervention provider will be aware of the intervention they receive, whereas the principal investigator and outcome assessor will remain blinded to the participants’ group assignments.

Only a portion of the data, such as information related to the primary outcome, can be shared.

One year after publication of the results.

Researchers from academic, scientific, and research institutions, subject to approval by the researcher and compliance with data confidentiality requirements.

Maintaining data confidentiality, using the data solely for scientific and research purposes, and not transferring the data to third parties.

Applicants may submit their requests to the researcher of the study. Requests will be processed upon approval by the researcher and in accordance with the relevant regulations.

Upon receipt of the applicant’s request and approval by the researcher, the de-identified data or documents will be provided to the applicant within a maximum of 30 days.