Development of dietary therapy for elderly CKD patients with sarcopenia

JRCT ID: jRCTs051210079

Registered date:07/09/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: CKD, sarcopenia
• Date of first enrollment: 18/12/2023
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Two groups: normal-protein rice and low-protein rice.

Outcome(s)

• Primary Outcome: 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

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

Key inclusion & exclusion criteria

• Age minimum: >= 65age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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.

Related Information

• Primary Sponsor: Kume Shinji