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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019881
Receipt No. R000022967
Scientific Title Effect of alcohol-metabolizing stimulation by ingestion of supplement containing freshwater clam extractive: a randomized, double blind, placebo-controlled cross over study
Date of disclosure of the study information 2015/11/20
Last modified on 2016/09/01

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Basic information
Public title Effect of alcohol-metabolizing stimulation by ingestion of supplement containing freshwater clam extractive: a randomized, double blind, placebo-controlled cross over study
Acronym Effect of alcohol-metabolizing stimulation by ingestion of supplement containing freshwater clam extractive
Scientific Title Effect of alcohol-metabolizing stimulation by ingestion of supplement containing freshwater clam extractive: a randomized, double blind, placebo-controlled cross over study
Scientific Title:Acronym Effect of alcohol-metabolizing stimulation by ingestion of supplement containing freshwater clam extractive
Region
Japan

Condition
Condition Healthy adult
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study aims to evaluate improvement effects of alcohol-metabolizing stimulation by ingestion of supplement containing freshwater clam extractive consecutively for 7 days on healthy adult.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes blood-alcohol content (before and after ingestion of supplement for 7 days, and just before and just after alcohol drinking)
Key secondary outcomes calculation test (the morning after alcohol drinking), subjective evaluation (before and after ingestion of supplement for 7 days)

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 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Intake test sample for 7 days, and take wash out period for 2 week, then intake placebo for 7 days.
Interventions/Control_2 Intake placebo for 7 days, and take wash out period for 2 week, then intake test sample for 7 days.
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
30 years-old <=
Age-upper limit
69 years-old >=
Gender Male and Female
Key inclusion criteria 1. Male and female between 30 and 69 years of age
2. Subjects who are able to drink alcohol.
Key exclusion criteria 1. Subjects with food allergies
2. Subjects who are pregnant or lactating
3. Subjects who consume medicinal product which may influence the outcome of the study
4.Subjects who consume food which may influence the outcome of the study
5. Subjects who are judged as unsuitable for the study by the investigator for other reasons
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masatomo Najima
Organization Japan clinical trial association
Division name N.A.
Zip code
Address 8F, 5-27-3 sendagaya, shibuyaku, Tokyo
TEL 03-6457-4666
Email info@yakujihou.org

Public contact
Name of contact person
1st name
Middle name
Last name Hirohisa Kojima
Organization Japan clinical trial association
Division name N.A.
Zip code
Address 8F, 5-27-3 sendagaya, shibuyaku, Tokyo
TEL 03-6457-4666
Homepage URL
Email info@yakujihou.org

Sponsor
Institute Japan clinical trial association
Institute
Department

Funding Source
Organization Yawata Corporation
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
2015 Year 11 Month 20 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
2015 Year 10 Month 29 Day
Date of IRB
Anticipated trial start date
2015 Year 11 Month 20 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
2015 Year 11 Month 20 Day
Last modified on
2016 Year 09 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022967

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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