UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of intake of supplement containing soy isoflavone extracts on adult women
Title of the study (Brief title)	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	Kuniyoshi Shimizu
Organization	Faculty of Agriculture, Kyushu University
Division name	Laboratory of Systematic Forest and Forest Products Science
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	Kuniyoshi Shimizu
Organization	Faculty of Agriculture, Kyushu University
Division name	Laboratory of Systematic Forest and Forest Products Science
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 06 Month 22 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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