NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs051210079

Registered date:07/09/2021

Development of dietary therapy for elderly conservative CKD patients with sarcopenia

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedCKD, sarcopenia
Date of first enrollment07/09/2021
Target sample size20
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Two groups: normal-protein rice and low-protein rice.

Outcome(s)

Primary OutcomeChanges 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 Outcome1 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

Key inclusion & exclusion criteria

Age minimum>= 65age old
Age maximumNot applicable
GenderBoth
Include criteria1. 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
Exclude criteria1. 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.

Related Information

Contact

Public contact
Name Naoko Takeda
Address Seta tsukinowa-cho Otsu-shi Shiga-ken Shiga Japan 520-2192
Telephone +81-77-548-2267
E-mail takedan@belle.shiga-med.ac.jp
Affiliation Shiga University of Medical Science
Scientific contact
Name Naoko Takeda
Address Seta tsukinowa-cho Otsu-shi Shiga-ken Shiga Japan 520-2192
Telephone +81-77-548-2267
E-mail takedan@belle.shiga-med.ac.jp
Affiliation Shiga University of Medical Science