NIPH Clinical Trials Search

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

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Rheumatoid arthritis
Date of first enrollment	23/10/2025
Target sample size	10
Countries of recruitment
Study type	Interventional
Intervention(s)	Take 10 g of immune protein daily for 8 weeks.

Outcome(s)

Primary Outcome

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 Outcome

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

Key inclusion & exclusion criteria

Age minimum	>= 20age old
Age maximum	<= 75age old
Gender	Both
Include 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.
Exclude criteria	1) The most recent test results within 90 days prior to enrollment indicate severe renal dysfunction (eGFR < 30 mL/min/1.73 m2) or hepatic dysfunction (AST > 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.