UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031537
Receipt number R000036008
Scientific Title A confirmation test of enhancing effect of the clam extract powder in alcohol metabolism
Date of disclosure of the study information 2018/03/01
Last modified on 2018/05/01 12:59:26

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Basic information

Public title

A confirmation test of enhancing effect of the clam extract powder in alcohol metabolism

Acronym

A confirmation test of enhancing effect of the clam extract powder in alcohol metabolism

Scientific Title

A confirmation test of enhancing effect of the clam extract powder in alcohol metabolism

Scientific Title:Acronym

A confirmation test of enhancing effect of the clam extract powder in alcohol metabolism

Region

Japan


Condition

Condition

Healthy subjects

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To confirm enhancing effect of the clam extract powder in alcohol metabolism.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Concentration of acetaldehyde in blood at each measurement point, AUC of blood acetaldehyde, Concentration of alcohol in blood at each measurement point, AUC of blood alcohol

Key secondary outcomes

Efficacy evaluations : VAS questionnaire, alcohol in expired gas
Safety evaluation : Incidence of side effect and adverse events


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Conducting alcohol loading test after intake 2 capsules of the test-food1. More than 5 days pause period. Conducting alcohol loading test after intake 2 capsules of the test-food2. More than 5 days pause period. Conducting alcohol loading test after intake 2 capsules of the control-food.

Interventions/Control_2

Conducting alcohol loading test after intake 2 capsules of the test-food2. More than 5 days pause period. Conducting alcohol loading test after intake 2 capsules of the control-food. More than 5 days pause period. Conducting alcohol loading test after intake 2 capsules of the test-food1.

Interventions/Control_3

Conducting alcohol loading test after intake 2 capsules of the control-food. More than 5 days pause period. Conducting alcohol loading test after intake 2 capsules of the test-food1. More than 5 days pause period. Conducting alcohol loading test after intake 2 capsules of the test-food2.

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

Key inclusion criteria

1) Males over aged 20 when informed consent.
2) Subjects who can drink alcohol.
(Include subjects who are weak against alcohol from subjective symptom and subjects who don't have liver dysfunction by doctor's judge.)
3) Subjects who have received enough description of the clinical test, understanding about the clinical test and giving written informed consent.

Key exclusion criteria

1) Subjects who can't drink alcohol.
2) Subjects who showed strong positive reaction in patch test of alcohol.
3) Subjects who constantly use medicines suspected to have influence to the results of the clinical test. (Turmeric, shellfish, levers and other hangover supplements etc.)
4) Subjects who have previous and/or current medical history of serious disease in heart, liver, kidney, digestive organ.
5) Subjects who excessive alcohol intake.
6) Subjects who have extremely irregular dining habits, and subjects who have midnight work or irregular shift work.
7) Subjects who have previous medical history of drug and/or food allergy.
8) Subjects who are participating the other clinical tests. Subjects who participated within 4-weeks prior to the current study and/or who plan to participate the other clinical tests.
9) Subjects who donated over 200mL blood and/or blood components within the last one month to the current study.
10) Subjects who donated over 400mL blood and/or blood components within the last three month to the current study.
11) Subjects who will be collected over 1200mL blood and/or blood components, when the sampling amounts within the last twelve month are adding to the planned sampling amounts of this study.
14) Others those have been determined ineligible by principal investigator or sub-investigator.

Target sample size

12


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Ken-ichi Nagamine

Organization

NICHIREI BIOSCIENCES INC.

Division name

Research & Development

Zip code


Address

1-52-14,Kumegawa-cho, Higashimurayama-shi,Tokyo,189-0003, JAPAN

TEL

042-391-1100

Email

nagaminek@nichirei.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Makoto Ichinohe

Organization

CPCC Company Limited

Division name

Planning & Sales Department

Zip code


Address

4F Chusin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN

TEL

03-5297-3112

Homepage URL


Email

cpcc-contact@cpcc.co.jp


Sponsor or person

Institute

CPCC Company Limited

Institute

Department

Personal name



Funding Source

Organization

NICHIREI BIOSCIENCES INC.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2018 Year 03 Month 01 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


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 02 Month 15 Day

Date of IRB


Anticipated trial start date

2018 Year 03 Month 02 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 03 Month 01 Day

Last modified on

2018 Year 05 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036008


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name