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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033124
Receipt No. R000037775
Scientific Title Effect of intake of supplement containing soy isoflavone extracts on adult women
Date of disclosure of the study information 2018/06/25
Last modified on 2018/11/02

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Basic information
Public title Effect of intake of supplement containing soy isoflavone extracts on adult women
Acronym Soy isoflavone extracts clinical trial
Scientific Title Effect of intake of supplement containing soy isoflavone extracts on adult women
Scientific Title:Acronym Soy isoflavone extracts clinical trial
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the efficacy of soy isoflavone component supplement for improving mental health in adult women
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Profile of Mood States
The Pittsburgh Sleep Quality Index
Cancer Fatigue Scale
Key secondary outcomes Saliva Immunoglobulin A
Saliva Cortisol
Blood pressure

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 To intake supplements containing plant extracts 3 tablets per day for 6 weeks
Interventions/Control_2 To intake placebo 3 tablets per day for 6
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
20 years-old <=
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria (1) Persons who is generally judged as healthy
(2) Persons who feel sleepy or stress during the day
(3) Persons who can give voluntary written consent to participate in the present trial
Key exclusion criteria (1) Persons who have any dietary supplements, quasi drugs or medicines which cause same or similar efficacy with the effect evaluated in this study
(2) Persons who have changed their habitats to take supplements within past 4 weeks.
(3) Persons who work in night shift or in day and night shift
(4) Persons who have been treated their illness or prevention in a clinic at their informed consent
(5) Persons with their medical histories as follows: serious diseases of sugar metabolism, lipid metabolism, hepatic function, renal function, heart, circulatory, respiratory, endocrine system, immune system, or mental illness of the nervous system
(6) Persons with the medical histories of alcoholism or drug dependence
(7) Persons who might be developed allergic reaction to foods.
(8) Persons who are pregnant, breast-feeding, or hope to be pregnant during the study period
(9) Persons who had always participated in or will participate in any other clinical trial (to use foods/medicine/quasi medicine/medical device)
(10) Persons who will not be judged suitable to the participants by the investigator.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kuniyoshi Shimizu
Organization Faculty of Agriculture, Kyushu University
Division name Laboratory of Systematic Forest and Forest Products Science
Zip code
Address 744 Motooka, Nishi-ku, Fukuoka, Fukuoka, JAPAN
TEL 092-802-4673
Email shimizu@agr.kyushu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kuniyoshi Shimizu
Organization Faculty of Agriculture, Kyushu University
Division name Laboratory of Systematic Forest and Forest Products Science
Zip code
Address 744 Motooka, Nishi-ku, Fukuoka, Fukuoka, JAPAN
TEL 092-802-4673
Homepage URL
Email shimizu@agr.kyushu-u.ac.jp

Sponsor
Institute Faculty of Agriculture, Kyushu University
Institute
Department

Funding Source
Organization NICHIMO BIOTICS CO.,LTD.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Faculty of Humanity-Oriented Science and Engineering, Kindai University
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 06 Month 25 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 06 Month 22 Day
Date of IRB
Anticipated trial start date
2018 Year 06 Month 25 Day
Last follow-up date
2018 Year 08 Month 10 Day
Date of closure to data entry
2018 Year 08 Month 17 Day
Date trial data considered complete
2018 Year 08 Month 17 Day
Date analysis concluded
2018 Year 10 Month 31 Day

Other
Other related information

Management information
Registered date
2018 Year 06 Month 23 Day
Last modified on
2018 Year 11 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037775

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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