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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016222
Receipt No. R000018826
Scientific Title Effectiveness of fermented drink : a randomized, double blind, placebo-controlled study
Date of disclosure of the study information 2015/01/15
Last modified on 2015/07/23

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Basic information
Public title Effectiveness of fermented drink : a randomized, double blind, placebo-controlled study
Acronym Effectiveness of fermented drink
Scientific Title Effectiveness of fermented drink : a randomized, double blind, placebo-controlled study
Scientific Title:Acronym Effectiveness of fermented drink
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 the effects of consumption of fermented drink contains extracts from culture of effective microorganisms for 12 consecutive weeks on antioxidative potency, anti-inflammatory efficacy and immune strength for the subjects who feel stress or tiredness.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes antioxidative potency, anti-inflammatory efficacy, immune strength
Key secondary outcomes QOL, safety

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
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 Ingestion of fermented drink for 12 consecutive weeks
Interventions/Control_2 Ingestion of placebo for 12 consecutive weeks
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
59 years-old >=
Gender Male and Female
Key inclusion criteria 1. Male and female between 30 and 59 years of age inclusive
2. Stress or tiredness
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 the other reason
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masatomo Najima
Organization Japan clinical trial assosiation
Division name N.A.
Zip code
Address 3F, 3-2-27 nishishinjuku, shinjukuku, Tokyo
TEL 03-6729-0350
Email info@yakujihou.org

Public contact
Name of contact person
1st name
Middle name
Last name Hirohisa Kojima
Organization Japan clinical trial assosiation
Division name N.A.
Zip code
Address 3F, 3-2-27 nishishinjuku, shinjukuku, Tokyo
TEL 03-6729-0350
Homepage URL
Email info@yakujihou.org

Sponsor
Institute Japan clinical trial assosiation
Institute
Department

Funding Source
Organization EM Seikatsu Co. Ltd.
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 01 Month 15 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
2014 Year 12 Month 17 Day
Date of IRB
Anticipated trial start date
2015 Year 01 Month 17 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 01 Month 15 Day
Last modified on
2015 Year 07 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018826

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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