Establishment of nutritional therapy for prevention of sarcopenia in patients with autoimmune and rheumatic diseases

JRCT ID: jRCT1043230167

Registered date:11/03/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Autoimmune and rheumatic diseases
• Date of first enrollment: 13/02/2024
• Target sample size: 56
• Study type: Interventional
• Intervention(s): Provide BCAA-rich supplements and intervention with exercise support from a physical therapist

Outcome(s)

• Primary Outcome: Difference in SMI change at 4 weeks between treatment groups
• Secondary Outcome: The association will be evaluated by a linear regression model with the SMI value at 4 weeks as the objective variable and risk factors (age, BMI, and gender) as explanatory variables.

Key inclusion & exclusion criteria

• Age minimum: >= 16age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(1) Patients who have given their free and voluntary written consent to participate in this study after receiving full explanation and with full understanding
(2) Patients aged 16 years or older, regardless of gender
(3) Patients who have been diagnosed with rheumatoid/ collagen diseases and related diseases by the time of enrollment
(4) Patients who were admitted to our department.

Exclude criteria

(1) Patients requiring urgent treatment
(2) Patients undergoing treatment for malignant diseases
(3) Patients with severe renal disease
(4) Patients with severe hepatic disorder
(5) Other patients who are judged to be inappropriate by the physician

Related Information

• Primary Sponsor: Yabe Daisuke
• Source(s) of Monetary Support: Japan Society of Metabolism and Clinical Nutrition