UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigation on time course of blood uric acid level after intake of nucleic acid containing food
Title of the study (Brief title)	Investigation on time course of blood uric acid level after intake of nucleic acid containing food
Region	Japan

Condition
Condition	Normal healthy subjects
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Investigation on time course of blood uric acid level after intake of nucleic acid containing food
Basic objectives2	Others
Basic objectives -Others	Investigation on intestinal absorption and metabolism of foodstuff
Trial characteristics_1	Others
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Concentration of serum uric acid
Key secondary outcomes	Creatinine, LDL cholesterol level, HDL cholesterol level, neutral fat, total cholesterol level, blood glucose level

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	nucleic acid containing food
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.Persons who have full ethical and regulatory approval and themselves and parental guardian give written informed consent 2.Healthy men and women who have serum uric acid value less than 8.0 mg / dL, and have never suffered a gout symptom 3.Healthy Japanese over 20 years old
Key exclusion criteria	1.Persons receiving medications such as uric acid levels, hypertension, diabetes, etc. 2.Pregnancy, breast-feeding, or pregnancy planning person 3.Those who are scheduled to undergo surgery / hospitalization, etc. for two months before and after the examination period (November 2017 to February 2018)
Target sample size	7

Research contact person
Name of lead principal investigator	Shuichi Segawa
Organization	SAPPORO HOLDINGS Ltd.
Division name	Frontier Laboratory for Value Creation
Address	10 Okatohme, Yaizu city, Shizuoka, 425-0013 JAPAN
TEL	054-629-7982
Email	Syuuichi.segawa@sapporoholdings.co.jp

Public contact
Name of contact person	Shuichi Segawa
Organization	SAPPORO HOLDINGS Ltd.
Division name	Frontier Laboratory for Value Creation
Address	10 Okatohme, Yaizu city, Shizuoka, 425-0013 JAPAN
TEL	054-629-7982
Homepage URL
Email	Syuuichi.segawa@sapporoholdings.co.jp

Sponsor
Institute	SAPPORO HOLDINGS Ltd.
Institute
Department

Funding Source
Organization	SAPPORO HOLDINGS Ltd.
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

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	2019 Year 04 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 12 Month 13 Day
Anticipated trial start date	2017 Year 12 Month 15 Day
Last follow-up date	2018 Year 03 Month 31 Day
Date of closure to data entry	2018 Year 04 Month 30 Day
Date trial data considered complete	2018 Year 04 Month 30 Day
Date analysis concluded	2018 Year 06 Month 30 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 12 Month 15 Day
Last modified on	2017 Year 12 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034728