UMIN-CTR Clinical Trial

Basic information
Public title	Research on the effect of green tea on uric acid metabolism after alcohol ingestion.
Acronym	Effect of green tea on uric acid metabolism after alcohol ingestion
Scientific Title	Research on the effect of green tea on uric acid metabolism after alcohol ingestion.
Scientific Title:Acronym	Effect of green tea on uric acid metabolism after alcohol ingestion
Region	Japan

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

Objectives
Narrative objectives1	To investigate the effect of green tea on uric acid metabolism after alcohol ingestion.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	uric acid levels
Key secondary outcomes	xanthine/hypoxanthine levels, Cua, FEUA

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is 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	Intake of a Japanese distilled spirit (shochu) with catechin-rich green tea
Interventions/Control_2	Intake of shochu with water
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	60 years-old >=
Gender	Male and Female
Key inclusion criteria	Those who received asufficient explanation of the purpose and contents of the study, who have the capacity to consent, voluntarily volunteer with sufficient understanding, and agree to participate in the document.
Key exclusion criteria	1.Currently, those who undergo medication for hyperuricemia or gout 2.Those who have an alcohol intolerance, are volnerable to alcohol , cannot drink alcohol 3.Those who are alcohol dependence 4.Those who are liver or renal dysfunction 5.Those who are pregnant or breastfeeding 6.Those who judged that the examination director and the test sharing doctor are inappropriate as subjects
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Hidekazu Middle name Last name Arai
Organization	The university of Shizuoka
Division name	Laboratory of Clinical Nutrition and Management, School of Food and Nutritional Sciences
Zip code	422-8526
Address	52-1 Yada, Suruga-ku, Shizuoka 422-8526, Japan
TEL	054-264-5511
Email	arai@u-shizuoka-ken.ac.jp

Public contact
Name of contact person	1st name Hidekazu Middle name Last name Arai
Organization	The university of Shizuoka
Division name	Laboratory of Clinical Nutrition and Management, School of Food and Nutritional Sciences
Zip code	422-8526
Address	52-1 Yada, Suruga-ku, Shizuoka 422-8526, Japan
TEL	054-264-5511
Homepage URL
Email	arai@u-shizuoka-ken.ac.jp

Sponsor
Institute	The university of Shizuoka
Institute
Department

Funding Source
Organization	the Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor	None
Name of secondary funder(s)	None

IRB Contact (For public release)
Organization	The Ethics Committee of the University of Shizuoka
Address	52-1 Yada, Suruga-ku, Shizuoka 422-8526, Japan
Tel	054-264-5103
Email	tyous10@u-shizuoka-ken.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 04 Month 07 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	17
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	2018 Year 08 Month 08 Day
Date of IRB	2018 Year 08 Month 08 Day
Anticipated trial start date	2018 Year 08 Month 15 Day
Last follow-up date	2020 Year 03 Month 31 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 04 Month 06 Day
Last modified on	2021 Year 04 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045687