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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021005
Receipt No. R000024244
Scientific Title A study on the effect of the rice endosperm protein (REP) on the level of serum uric acid after high-purine diet intake.
Date of disclosure of the study information 2016/02/13
Last modified on 2020/10/05

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Basic information
Public title A study on the effect of the rice endosperm protein (REP) on the level of serum uric acid after high-purine diet intake.
Acronym A study on the effect of the rice endosperm protein (REP) on serum uric acid level.
Scientific Title A study on the effect of the rice endosperm protein (REP) on the level of serum uric acid after high-purine diet intake.
Scientific Title:Acronym A study on the effect of the rice endosperm protein (REP) on serum uric acid level.
Region
Japan

Condition
Condition Healthy male adult
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effect of rice endosperm protein on serum uric acid level.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes AUC of serum uric acid level during 24-hrs after test food intake.
Key secondary outcomes Serum uric acid at each time point and that in urine collection after test food loading.

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Single intake of high-purine drink and the food which include rice endosperm protein. - Washout 1-week. - Single intake of high-purine drink and the food which doesn't include rice endosperm protein.
Interventions/Control_2 Single intake of high-purine drink and the food which doesn't include rice endosperm protein. - Washout 1-week. - Single intake of high-purine drink and the food which include rice endosperm protein.
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
Key inclusion criteria (1) Males whose serum uric acid levels are included within 6.0mg/dL and 8.0mg/dL.
(2) Males aged 20 years old and over
(3) Subjects who possible to take a blood sample repeatedly with the passage of time
(4) Subjects who can make self-judgment and are voluntarily giving written informed consent.
Key exclusion criteria (1) Subjects who have severe disease in liver, kidney, heart, lung, digestive organ, blood, endocrine system or metabolic system.
(2)Subjects who have medical history of gouty arthritis, kidney disease or urinary stone.
(3) Subjects who are received treatment of high blood pressure continuously.
(4)Subjects who are received current treatment for diabetes mellitus.
(5)Subjects who are received a prescription of drugs for hyperlipidemia or blood sugar improvement.
(6) Heavy alcohol drinker.
(7)Subjects who have previous medical history of drug and/or food allergy.
(8)Subjects who participated another test of drug or food within 1-month.
(9)Subjects who have donated over 200 mL of blood and/or blood components within the last one month prior to the current study.
Subjects who have donated over 400 mL of blood and/or blood components within the last three months prior to the current study.
(10)Subjects who have donated over 400 mL of blood and/or blood components within the last three months prior to the current study.
(11)Shift workers.
(12) These having Food for Specified Health Uses (FOSHU) and/or health food.
(13)Subjects who have been determined ineligible by principal investigator or sub-investigator.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Suguru
Middle name
Last name Fujiwara
Organization CPCC Co.,Ltd.
Division name Clinical Research Planning Department
Zip code 101-0047
Address 4F Chushin Build. 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047 Japan
TEL 03-5297-3112
Email cpcc-contact@cpcc.co.jp

Public contact
Name of contact person
1st name Makoto
Middle name
Last name Ichinohe
Organization CPCC Co.,Ltd
Division name Plan Sales Department
Zip code 101-0047
Address 4F Chushin Build. 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047 Japan
TEL 03-5297-3112
Homepage URL
Email cpcc-contact@cpcc.co.jp

Sponsor
Institute CPCC Co.,Ltd
Institute
Department

Funding Source
Organization KAMEDA SEIKA CO., LTD.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Institutional Review Board of Chiyoda Paramedical Care Clinic
Address 2F Chushin Build. 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047 Japan
Tel 03-5297-5548
Email IRB@cpcc.co.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
2016 Year 02 Month 13 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
2016 Year 01 Month 22 Day
Date of IRB
Anticipated trial start date
2016 Year 02 Month 13 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 02 Month 13 Day
Last modified on
2020 Year 10 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024244

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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