UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041832 |
|---|---|
| Receipt number | R000047757 |
| Scientific Title | A study for evaluating the effect of low-protein brown rice on intestinal flora in patients with chronic kidney disease. |
| Date of disclosure of the study information | 2020/09/18 |
| Last modified on | 2023/09/25 14:42:00 |
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Basic information
Public title
A study for evaluating the effect of low-protein brown rice on intestinal flora in patients with chronic kidney disease.
Acronym
A study for evaluating the effect of low-protein brown rice on intestinal flora in patients with chronic kidney disease.
Scientific Title
A study for evaluating the effect of low-protein brown rice on intestinal flora in patients with chronic kidney disease.
Scientific Title:Acronym
A study for evaluating the effect of low-protein brown rice on intestinal flora in patients with chronic kidney disease.
Region
| Japan |
Condition
Condition
Chronic kidney disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of 12 weeks of low-protein brown rice consumption on intestinal flora in patients with chronic kidney disease. The primary endpoint was the evaluation of the intestinal flora before and after the introduction of low-protein brown rice. As a secondary endpoint, an inflammatory component related to changes in the intestinal flora should be considered. (IL -6, leptin, indoxyl sulfate, p-cresyl sulfate, microRNA, exosome)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
After obtaining the consent, participants will stop using probiotics such as yogurt for three months. After the initial assessment, participants consume a low-protein diet for 3 months and undergo a second assessment. After that, low-protein brown rice is consumed for 3 months and the final evaluation is performed. The intestinal flora is checked at each evaluation.
Key secondary outcomes
Assessment of inflammation-related parameters at each time point. (IL -6, leptin, indoxyl sulfate, p-cresyl sulfate, microRNA, exosome)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
After obtaining the consent, participants will stop using probiotics such as yogurt for three months. Participants then eat a protein-restricted diet for three months. Over the next three months, one retort pack (150g) of low-protein brown rice is taken as one serving, and a total of 10 servings are eaten a week.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Outpatients with CKD stage 3 or lower. (eGFR less than 59 ml/min/1.73 m2, not including dialysis patients) .
2) Those who have not received protein restriction therapy.
3) Patients from whom written informed consent was obtained.
Key exclusion criteria
1) Patients in whom it is difficult to obtain sufficient samples for analysis.
2) Patients who have cognitive or physical impairments that make it difficult to follow a diet.
3) Patients with inflammatory bowel disease.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Shu |
| Middle name | |
| Last name | Wakino |
Organization
Department of internal medicine, Keio University, School of Medicine
Division name
Division of Endocrinology, Metabolism and Nephrology
Zip code
160-8582
Address
35-banchi, Shinano-machi ,Shinjuku-ku,Tokyo, Japan
TEL
+81-3-3353-1211
shuwakino@z8.keio.jp
Public contact
Name of contact person
| 1st name | Keika |
| Middle name | |
| Last name | Adachi |
Organization
Department of internal medicine, Keio University, School of Medicine
Division name
Division of Endocrinology, Metabolism and Nephrology
Zip code
160-8582
Address
35-banchi, Shinano-machi ,Shinjuku-ku,Tokyo, Japan
TEL
+81-3-3353-1211
Homepage URL
keika@a7.keio.jp
Sponsor or person
Institute
Division of Endocrinology, Metabolism and Nephrology Department of Internal Medicine Keio University, School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Medical Rice Association
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
Forica Foods Co., Ltd.
IRB Contact (For public release)
Organization
Keio University Hospital Clinical and Translational Research Center
Address
35-banchi, Shinano-machi ,Shinjuku-ku,Tokyo, Japan
Tel
+81-3-5363-3961
med-rinri-jimu@adst.keio.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 09 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 09 | Month | 09 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 18 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 09 | Month | 18 | Day |
Last modified on
| 2023 | Year | 09 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047757
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