臨床研究等提出・公開システム

Japanese

Date of registration	Sept. 07, 2021
Last modified on	Dec. 28, 2023
Trial ID	jRCTs051210079

Scientific Title	Development of dietary therapy for elderly CKD patients with sarcopenia
Public Title	Development of dietary therapy for elderly CKD patients with sarcopenia

Contact for Scientific Queries	Name	Kume Shinji
	Affiliation	Shiga University of Medical Science
	Address	Seta tsukinowa-cho Otsu-shi Shiga-ken
	Telephone	+81-77-548-2267
	E-mail	skume@belle.shiga-med.ac.jp
Contact for Public Queries	Name	Kume Shinji
	Affiliation	Shiga University of Medical Science
	Address	Seta tsukinowa-cho Otsu-shi Shiga-ken
	Telephone	+81-77-548-2267
	E-mail	skume@belle.shiga-med.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Sept. 07, 2021
Actual date of first enrollment		Dec. 18, 2023
Target sample size		20
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	open(masking not used)
	control	active control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1. Men and women aged 65 years or older 2. Patients with CKD stage 3 or 4 (eGFR 15 to 59ml/min/1.73m2) 3. Patients who meet the diagnostic criteria for asia sarcopenia working group 2019 4. Patients who have given written consent
	Exclusion Criteria	1. Patients who are unable to perform exercise therapy focusing on the lower body 2. Patients whose eGFR rate of decline exceeds -5 ml/min/1.73 m2/year 3. Patients who have dementia and have difficulty in implementing diet and exercise therapy 4. Patients on steroid therapy 5. Patients undergoing chemotherapy 6. Patients with dysphagia 7. Patients under 140 cm tall and over 170 cm tall 8. Patients with poor glycemic control (HbA1c 8.0% or more) 9. Patients with liver cirrhosis 10.Other patients deemed inappropriate for participation in this study.
	Age Minimum	65age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		CKD, sarcopenia
Intervention(s)		Two groups: normal-protein rice and low-protein rice.
Health Condition(s) Keyword		CKD, sarcopenia
Intervention(s) Keyword		protein restriction, low protein rice, exercise therapy
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Changes in body composition (muscle mass measured by DEXA method) and renal function (GFR measured by cystatin C) at the beginning of the dietary intervention and after 12 weeks
Secondary Outcome(s)		1 Changes in urinary protein (24 hour urine storage) at the beginning and after 12 weeks of dietary intervention 2 Changes in nutritional indices (serum albumin, prealbumin, total cholesterol, triglycerides, transferrin), physical functions (knee muscle strength, grip strength, normal walking speed, maximum walking speed), and protein intake (24 hour urine storage, estimated intake by dietary survey) between the start of the dietary intervention and 12 weeks later 3 Changes in the ratio of animal to vegetable protein intake (estimated intake by dietary survey) at the beginning of the dietary intervention and after 12 weeks. 4 Changes in body composition, renal function and proteinuria, and protein intake after 12 weeks of follow up after the end of the dietary intervention

Primary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Shiga University of Medical Science Clinical Research Review Board
Address	Seta Tsukinowa-cho, Otsu, Shiga, JAPAN, Shiga
Telephone	+81-77-548-3576
E-Mail	hqrec@belle.shiga-med.ac.jp
Approval Status	Approval
Date of approval	July. 20, 2021

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	None

History of Changes

No	Publication date
6	Dec. 28, 2023	(this page)	Changes
5	Nov. 28, 2023	Detail	Changes
4	May. 25, 2022	Detail	Changes
3	May. 13, 2022	Detail	Changes
2	Feb. 08, 2022	Detail	Changes
1	Sept. 07, 2021	Detail

List of change history