Unique ID issued by UMIN | UMIN000010876 |
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Receipt number | R000012726 |
Scientific Title | The effect of rice protein supplement on nutritional and metabolic status in prevalent hemodialysis patients: a randomized double-blind cross-over study |
Date of disclosure of the study information | 2013/06/10 |
Last modified on | 2016/05/06 17:20:37 |
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
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
Japan |
End stage kidney disease requiring maintenance hemodialysis
Nephrology |
Others
NO
To evaluate the effect of rice protein supplement on nutritional and metabolic status in prevalent hemodialysis patients with low protein intake
Efficacy
Confirmatory
Pragmatic
Not applicable
Change in protein intake estimated by normalized protein nitrogen appearance (nPNA)
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
Interventional
Cross-over
Randomized
Individual
Double blind -all involved are blinded
Placebo
YES
NO
Institution is considered as a block.
No need to know
2
Treatment
Food |
Once-daily jelly supplement containing 5 g rice protein for 4 weeks
Once-daily jelly supplement not containing rice protein for 4 weeks
20 | years-old | <= |
Not applicable |
Male and Female
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
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
50
1st name | |
Middle name | |
Last name | Akihiko Saito |
Niigata University Graduate School of Medical and Dental Sciences
Department of Applied Molecular Medicine
1-757 Asahimachi-dori, Chuo-ku, Niigata-shi
025-227-0915
1st name | |
Middle name | |
Last name | Akihiko Saito |
Niigata University Graduate School of Medical and Dental Sciences
Department of Applied Molecular Medicine
1-757 Asahimachi-dori, Chuo-ku, Niigata-shi
025-227-0915
akisaito@med.niigata-u.ac.jp
Department of Applied Molecular Medicine, Niigata University Graduate School of Medical and Dental Sciences
The Ministry of Agriculture, Forestry and Fisheries
Japan
NO
新潟大学医歯学総合病院(新潟県)、信楽園病院(新潟県)、向陽メディカルクリニック(新潟県)
2013 | Year | 06 | Month | 10 | Day |
Unpublished
Completed
2013 | Year | 07 | Month | 17 | Day |
2013 | Year | 07 | Month | 29 | Day |
2014 | Year | 02 | Month | 28 | Day |
2014 | Year | 04 | Month | 01 | Day |
2014 | Year | 05 | Month | 01 | Day |
2014 | Year | 06 | Month | 01 | Day |
2013 | Year | 06 | Month | 04 | Day |
2016 | Year | 05 | Month | 06 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012726
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