UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040076
Receipt number 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 2021/04/06 19:08:22

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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 or person

Institute

The university of Shizuoka

Institute

Department

Personal name



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

Value
https://center6.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