UMIN-CTR Clinical Trial

Public title

Efficacy of liver function (alcohol metabolism) by ingestion of supplement containing plant derived extractive on healthy adult

Acronym

Efficacy of liver function (alcohol metabolism) by ingestion of supplement containing plant derived extractive on healthy adult

Scientific Title

Efficacy of liver function (alcohol metabolism) by ingestion of supplement containing plant derived extractive on healthy adult

Scientific Title:Acronym

Efficacy of liver function (alcohol metabolism) by ingestion of supplement containing plant derived extractive on healthy adult

Region

Japan

Condition

Healthy subjects

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate the efficacy of liver function by ingestion of supplement containing plant derived extractive

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Area under the blood alcohol curve

Key secondary outcomes

Peak in blood alcohol concentration, breath alcohol concentration, area under the breath alcohol curve, blood alcohol concentration and breath alcohol concentration at 30, 60, 90, 120, and 180 min after alcohol ingestion, and questionnaire survey

Study type

Interventional

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

NO

Dynamic allocation

NO

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Intake the test food, and take wash out period for 1 week, then intake the placebo food

Interventions/Control_2

Intake the placebo food, and take wash out period for 1 week, then intake the test food

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

59

years-old

>=

Gender

Male

Key inclusion criteria

1. Healthy males who have a drinking habit, aged 20-59 years old
2. Subjects estimated that genotypes is NN or ND type in alcohol patch test
3. Subjects who can drink alcohol effortlessly

Key exclusion criteria

1. Subjects who constantly use supplements including Functional substances
2. Subjects estimated no to be able to drink alcohol by patch test etc.
3. Subjects who constantly use supplements or drug affecting the liver function
4. Subjects with chronic illness or medication
5. Subjects with easy-to-GI disease (particularly alcohol easy to be diarrhea)
6. Subjects who has oral trouble
7. Subjects who has serious illness such as diabetes, liver disease, kidney disease, heart disease
8. Subjects with allergies to the test food or alcohol in the study
9. Subjects with excessive smoking
10. Subjects who drink alcohol a lot
11. Subjects who work at night or have irregular life more than one time in the study
12. Subjects who have participated in other clinical study within the last one month or have plan to participate other clinical studies
13. Subject who are judged as unsuitable for the study from clinical measurements for preliminary tests and measurements
14. Subjects who are judged as unsuitable for the study from questionnaire
15. Subjects who are judged as ineligible by clinical investigator

Target sample size

20

Name of lead principal investigator

1st name
Middle name
Last name	Kazuyuki Mizuyama

Organization

Doujin Memorial Foundation Meiwa Hospital

Division name

Internal Medicine

Zip code

Address

1-18, Kandasudacho, Chiyoda-ku, Tokyo

TEL

03-5543-0186

Email

research@smo-msr.co.jp

Name of contact person

1st name
Middle name
Last name	Takashi Nakagawa

Organization

TTC Co., Ltd.

Division name

Clinical Research Planning Department

Zip code

Address

Seibu Shinkin Bank Ebisu Bldg.,1-20-2, Ebisunishi, Shibuya-ku, Tokyo

TEL

03-5459-5329

Homepage URL

Email

t.nakagawa@ttc-tokyo.co.jp

Institute

TTC Co., Ltd.

Institute

Department

Personal name

Organization

Shiratori Pharmaceutical Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2016

Year

07

Month

29

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

Number of participants that the trial has enrolled

Results

Jpn. Pharmacol. Ther. 2017, 45(5), 781-90

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

Recruitment status

Completed

Date of protocol fixation

2016

Year

07

Month

13

Day

Date of IRB

Anticipated trial start date

2016

Year

07

Month

30

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2016

Year

07

Month

23

Day

Last modified on

2017

Year

08

Month

04

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026805