Effect of long-term intake of immune protein on clinical symptoms and inflammation-related indicators in patients with rheumatoid arthritis

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs061250052

Enrollment

Registered

2025-09-05

Start date

2025-10-23

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid arthritis

Interventions

Take 10 g of immune protein daily for 8 weeks.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Men and women aged 20 to 75 years old. 2) Diagnosed with rheumatoid arthritis based on the ACR/EULAR 2010 classification criteria and undergoing treatment. 3) Able to maintain normal daily activities, including protein intake, during the study period. 4) Able to continue daily consumption of the investigational food at the specified dose for 8 weeks. 5) Written informed consent obtained from the participant.

Exclusion criteria

Exclusion criteria: 1) The most recent test results within 90 days prior to enrollment indicate severe renal dysfunction (eGFR 100 IU/L or ALT > 100 IU/L). 2) Pregnant women, women who may be pregnant, or breastfeeding women. 3) Has an allergy to dairy products or lactose intolerance. 4) Regularly consumed immune proteins similar to the investigational food or health foods/supplements that could affect the trial within 3 months prior to enrollment. 5) Experienced changes in medical condition or medication within 3 months prior to enrollment.

Design outcomes

Primary

Measure	Time frame
Changes in joint pain (VAS), DAS28 (Disease Activity Score-28), SDAI (Simplified Disease Activity Index), CDAI (Clinical Disease Activity Index), and m-HAQ (modified Health Assessment Questionnaire) before and after intervention	—

Secondary

Measure	Time frame
Changes in blood test values before and after intervention - Routine diagnostic items: fasting blood glucose, HbA1c, triglycerides, HDL cholesterol, LDL cholesterol, total protein, albumin, immunoglobulin, inflammatory markers (high-sensitivity CRP, MMP-3), RF, ESR, ANA - Research-specific measurements: Inflammation-related markers (cytokines), intestinal injury markers (I-FABP), muscle injury markers (Titin, CK), oxidative stress markers (d-ROMs, BAP), RNAseq Incidence of adverse events	—

Measure

Time frame

Changes in blood test values before and after intervention - Routine diagnostic items: fasting blood glucose, HbA1c, triglycerides, HDL cholesterol, LDL cholesterol, total protein, albumin, immunoglobulin, inflammatory markers (high-sensitivity CRP, MMP-3), RF, ESR, ANA - Research-specific measurements: Inflammation-related markers (cytokines), intestinal injury markers (I-FABP), muscle injury markers (Titin, CK), oxidative stress markers (d-ROMs, BAP), RNAseq Incidence of adverse events

—

Contacts

Public ContactKunihiro Ichinose

Shimane University, Faculty of Medicine

kichinose@med.shimane-u.ac.jp+81-853-20-2196

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026