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Study on the safety and effectiveness of rice protein intake in maintenance hemodialysis patients

Study on the safety and effectiveness of rice protein intake in maintenance hemodialysis patients - Niigata KOME (key evaluation of rice proteins' medical benefits) study 2

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000009235
Enrollment
10
Registered
2012-11-01
Start date
2012-11-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic renal failure (maintenance hemodialysis)

Interventions

Intake of rice proteins (5g/day) for 2 weeks

Sponsors

Department of Applied Molecular Medicine, Niigata University Graduate School of Medical and Dental Sciences
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Adult male or female maintenance hemodialysis patients who fulfill the following criteria will be included in the study: 1) Tendency of malnutrition (serum albumin concentration = or < 8mg/dl and BMI = or < 22kg/m2) 2) Those who have given written informed consent on the use of their data for the study

Exclusion criteria

Exclusion criteria: 1) Those with severe heart or liver disease 2) Those at perioperative stages, or those with severe infection or serious injury 3) Those with food allergy 4) Those who are considered not eligible for the study by attending doctors due to any medical reasons

Design outcomes

Primary

MeasureTime frame
Changes in serum phosphate, calcium, sodium, potassium and magnesium concentrations

Secondary

MeasureTime frame
Changes in the following parameters during the observation period: 1) Clinical symptoms (abdominal symptoms etc) 2) Body weight, BMI, muscle volume and body fat composition 3) Nutritional, metabolic and inflammatory parameters Adverse events are analyzed with Common Terminology Criteria for Adverse Events v4.0-JCOG when they happen.

Countries

Japan

Contacts

Public ContactAkihiko Saito

Niigata University Graduate School of Medical and Dental Sciences Department of Applied Molecular Medicine

akisaito@med.niigata-u.ac.jp025-227-0915

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026