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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000036305
Receipt No. R000041352
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-
Date of disclosure of the study information 2020/08/30
Last modified on 2020/10/09

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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

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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