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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031537
Receipt No. 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

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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
Institute CPCC Company Limited
Institute
Department

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
URL(English) https://upload.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


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