The effect of rice protein supplement on nutritional and metabolic status in prevalent hemodialysis patients: a randomized double-blind cross-over study

The effect of rice protein supplement on nutritional and metabolic status in prevalent hemodialysis patients: a randomized double-blind cross-over study - Niigata KOME (key evaluation of rice proteins' medical benefits) study 3

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000010876

Enrollment

Registered

2013-06-10

Start date

2013-07-29

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

End stage kidney disease requiring maintenance hemodialysis

Interventions

Once-daily jelly supplement containing 5 g rice protein for 4 weeks Once-daily jelly supplement not containing rice protein for 4 weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Adult prevalent hemodialysis patients who fulfill the following criteria will be included in the study: 1) Serum albumin concentration of< (or =) 3.8mg/dl 2) Body mass index of > (or =) 19 and <23 kg/m2 3) Dry weight 6 months ago is within 95-105% of current one 4) Normalized protein equivalent of nitrogen appearance (nPNA) of < 1.2g/kg/day 5) Those who have undergone maintenance hemodialysis for more than 2 years 6) 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 3) Those at perioperative stages, or those with severe infection or serious injury 4) Those with food allergy 5) Those who are considered not eligible for the study by attending doctors due to any medical reasons

Design outcomes

Primary

Measure	Time frame
Change in protein intake estimated by normalized protein nitrogen appearance (nPNA)	—

Secondary

Measure	Time frame
1) Objective score of nutrition on dialysis 2) Body composition estimates using direct segmental multi-frequency bioelectrical impedance analysis (Inbody720, Biospace, Tokyo, Japan) 3) Self-reported adherence to the allocated supplement 4) Change in dietary patterns assessed by brief-type self- administered diet history questionnaire 5) Laboratory parameters associated with bone and mineral disorder (e.g. calcium, phosphate, parathyroid hormone, and fibroblast growth hormone 23 6) Uric acid 7) Gastrointestinal symptoms such as appetite loss, abdominal pain, diarrhea and constipation	—

Measure

Time frame

1) Objective score of nutrition on dialysis 2) Body composition estimates using direct segmental multi-frequency bioelectrical impedance analysis (Inbody720, Biospace, Tokyo, Japan) 3) Self-reported adherence to the allocated supplement 4) Change in dietary patterns assessed by brief-type self- administered diet history questionnaire 5) Laboratory parameters associated with bone and mineral disorder (e.g. calcium, phosphate, parathyroid hormone, and fibroblast growth hormone 23 6) Uric acid 7) Gastrointestinal symptoms such as appetite loss, abdominal pain, diarrhea and constipation

—

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