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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000040076
Receipt No. R000045687
Scientific Title Research on the effect of green tea on uric acid metabolism after alcohol ingestion.
Date of disclosure of the study information 2020/04/07
Last modified on 2020/04/08

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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 No longer recruiting
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
2020 Year 04 Month 08 Day


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

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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