UMIN-CTR Clinical Trial

Basic information
Public title	The effect confirmation study of usual consumption of test food -the 2nd preliminary verification of the effect of the test food which contain lactic acid bacteria for healthy adults-
Acronym	The 2nd preliminary effect verification of consumption of the test food which contain lactic acid bacteria
Scientific Title	The effect confirmation study of usual consumption of test food -the 2nd preliminary verification of the effect of the test food which contain lactic acid bacteria for healthy adults-
Scientific Title:Acronym	The 2nd preliminary effect verification of consumption of the test food which contain lactic acid bacteria
Region	Japan

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

Objectives
Narrative objectives1	Exploratory verification of effect of the test food, when consume usual amount for a certain period.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Productive availability of equol
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
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 food, 2 tablets a day, for four continuous weeks. Rest one month. Intake control food, 2 tablets a day, for four continuous weeks.
Interventions/Control_2	Intake control food, 2 tablets a day, for four continuous weeks. Rest one month. Intake test food, 2 tablets a day, for four continuous 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	60 years-old >=
Gender	Female
Key inclusion criteria	(1)Japanese healthy females aged 20 to 60 years old when consent acquisition. (2)Females who don't be given treatment by taking medicines, therapies and/or operations even seasonal, chronic or sudden case. (3)Females who show enough understanding of the clinical study procedures, and who agree with participating in the study by written informed consent from their own will. (4)Females those BMI are 18.5 to less than 30.0. (5)Females whose blood pressure (average from two times measurements) are within the conditions below. Systolic blood pressure is less or equal 139 mmHg. Diastolic blood pressure is less or equal 89 mmHg. (6)Females whose pulses are 40 to 100 times per minute. (7)Females whose body temperatures are 35.5 to 37.0 degrees Celsius. (8)Females who can prohibit excessive exercise during test period. (9)Females who basically take 3 meals a day and can prohibit drinking and eating too much. (10)Females who can contraception properly during test period. (11) Females who can understand and compliance to controlled matters.
Key exclusion criteria	(1) Females who have disorder that affect absorption, distribution, metabolism and/or excretion of test food, such as disease in digestive tract, liver, kidney, heart and/or circulation system. (2)Females who have surgery history in digestive tract such as gastrectomy, gastrointestinal suture surgery and/or intestinal resection etc., but except polypectomy and appendectomy. (3)Females who have medical history of cerebral vascular disorder. (4)Females who have specific constitution that occur allergy and/or hypersensitivity against test food. (5) Females who suspect to alcohol dependence and/or drug dependence. (6) Females who have attended other clinical trial and/or clinical study within 84 days before consent acquisition. (7) Females who have done 400mL of whole blood donation within 84 days before consent acquisition. Females who have done 200mL of whole blood donation within 28 days before consent acquisition. Females who have done 200mL of ingredient donation within 14 days before consent acquisition. (8)Females who are lactating and/or pregnant. (9) Females who engage in mid-night work.
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Yoshio Middle name Last name Nishida
Organization	Tokai Gakuen University
Division name	School of Health and Nutrition
Zip code	468-8514
Address	2-901 Nakahira, Tenpaku-ku, Nagoya-city, Aichi, 468-8514, JAPAN
TEL	052-801-1472
Email	nishid-y@tokaigakuen-u.ac.jp

Public contact
Name of contact person	1st name Atsuhisa Middle name Last name Nishimura
Organization	ICHIBIKI CO., LTD.
Division name	Research Laboratory
Zip code	441-8019
Address	110-2 Kinuta, Hanada-cho, Toyohashi-city, Aichi, 441-8019, JAPAN
TEL	0532-32-8776
Homepage URL
Email	technicalcenter@ichibiki.co.jp

Sponsor
Institute	Tokai Gakuen University
Institute
Department

Funding Source
Organization	ICHIBIKI 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	Institutional Review Board of Tokai Gakuen University
Address	2-901 Nakahira, Tenpaku-ku, Nagoya-city, Aichi, 468-8514, JAPAN
Tel	052-801-1201
Email	nishid-y@tokaigakuen-u.ac.jp

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	2020 Year 08 Month 30 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 11 Month 09 Day
Date of IRB	2019 Year 04 Month 26 Day
Anticipated trial start date	2019 Year 05 Month 16 Day
Last follow-up date	2019 Year 11 Month 21 Day
Date of closure to data entry	2019 Year 12 Month 05 Day
Date trial data considered complete	2020 Year 01 Month 28 Day
Date analysis concluded	2020 Year 01 Month 29 Day

Other
Other related information

Management information
Registered date	2019 Year 03 Month 27 Day
Last modified on	2020 Year 10 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041352