UMIN-CTR Clinical Trial

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