UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046788 |
|---|---|
| Receipt number | R000053375 |
| Scientific Title | The effect of the digestible protein-restricted rice intake on the protein digestion and absorption in healthy subjects: A Randomized Controlled Trials |
| Date of disclosure of the study information | 2022/02/14 |
| Last modified on | 2023/02/26 14:00:26 |
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Basic information
Public title
Research on protein digestion and absorption in original varieties rice for kidney disease
Acronym
Research on protein digestion and absorption in rice for kidney disease
Scientific Title
The effect of the digestible protein-restricted rice intake on the protein digestion and absorption in healthy subjects: A Randomized Controlled Trials
Scientific Title:Acronym
The effect of the digestible protein-restricted rice intake on the protein digestion and absorption: A Randomized Controlled Trials
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Medicine in general | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Patients with severe kidney disease are recommended to limit their protein intake. Therefore, the digestible protein-restricted rice can help their diet. The purpose of this study is to examine the absorption of protein after intake of digestible protein-restricted rice in healthy subjects by a randomized controlled trial with the primary outcome of protein intake (absorption) estimated by 24-hour urine collection.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Protein intake (absorption) estimated by 24-hour urine collection during the intervention period (3 days).
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Between day 1 and day 3, the participants consume low-protein rice for every meal. Between day 4 and day 6, the participants consume the original variety of rice for kidney disease for every meal.
Interventions/Control_2
Between day 1 and day 3, the participants consume low-protein rice for every meal. Between day 4 and day 6, the participants consume the control (normal) rice for every meal.
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
| 19 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
- The persons who can eat the provided meals for every meal during the study period.
- Body mass index is between 18.5 kg/m2 and 30 kg/m2.
Key exclusion criteria
- Pregnant or lactating women.
- The persons who are unsuited to participate in the study.
- The person who have food allergies.
- The persons who are undergoing treatment for malignant neoplasm, ischemic heart disease, cerebrovascular disease, renal failure, dementia, or severe digestive system disease at the time of the study.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Koutatsu |
| Middle name | |
| Last name | Maruyama |
Organization
Ehime University
Division name
Department of Bioscience, Graduate School of Agriculture
Zip code
7908566
Address
3-5-7 Tarumi, Matsuyama, Ehime
TEL
089-946-9960
maruyama.kotatsu.rt@ehime-u.ac.jp
Public contact
Name of contact person
| 1st name | Koutatsu |
| Middle name | |
| Last name | Maruyama |
Organization
Ehime University
Division name
Department of Bioscience, Graduate School of Agriculture
Zip code
7908566
Address
3-5-7 Tarumi, Matsuyama, Ehime
TEL
089-946-9960
Homepage URL
maruyama.kotatsu.rt@ehime-u.ac.jp
Sponsor or person
Institute
Ehime University
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ehime University
Address
Shitsukawa, Toon, Ehime
Tel
089-960-5040
rinri@m.ehime-u.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
| 2022 | Year | 02 | Month | 14 | 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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 11 | Month | 20 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 24 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 14 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2022 | Year | 05 | Month | 30 | Day |
Date analysis concluded
| 2022 | Year | 07 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 01 | Month | 31 | Day |
Last modified on
| 2023 | Year | 02 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053375
