臨床研究等提出・公開システム

Japanese

Date of registration	Mar. 11, 2024
Last modified on	Mar. 11, 2024
Trial ID	jRCT1043230167

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

Contact for Scientific Queries	Name	Yabe Daisuke
	Affiliation	Division of Rheumatology and Endocrinology
	Address	1-1 Yanagido Gifu 501-1194
	Telephone	+81-582306377
	E-mail	yabe.daisuke.s9@f.gifu-u.ac.jp
Contact for Public Queries	Name	Mizuno Masami
	Affiliation	Division of Rheumatology and Endocrinology
	Address	1-1 Yanagido Gifu 501-1194
	Telephone	+81-582306377
	E-mail	mizuno.masami.a6@f.gifu-u.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Feb. 13, 2024
Actual date of first enrollment
Target sample size		56
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	open(masking not used)
	control	placebo control
	assignment	single assignment
	purpose	prevention purpose
Key inclusion & exclusion criteria	Inclusion 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.
	Exclusion 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
	Age Minimum	16age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Autoimmune and rheumatic diseases
Intervention(s)		Provide BCAA-rich supplements and intervention with exercise support from a physical therapist
Health Condition(s) Keyword		Sarcopenia
Intervention(s) Keyword
Health Condition(s) Code		D012216
Intervention(s) Code
Primary Outcome(s)		Difference in SMI change at 4 weeks between treatment groups
Secondary Outcome(s)		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.

Primary Sponsor	none

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support	Japan Society of Metabolism and Clinical Nutrition
Secondary Sponsor	Not applicable

Name of Certified Review Board	Tokai National University Organization Gifu University Medical Research Ethics Review Committee
Address	1-1 Yanagido GIfu, Gifu
Telephone	+81-582306377
E-Mail	rinri@t.gifu-u.ac.jp
Approval Status	Approval
Date of approval	Feb. 13, 2024

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none