UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032409 |
|---|---|
| Receipt number | R000036958 |
| Scientific Title | The effect confirmation study of usual consumption of test food - a preliminary verification of the effect of the test food which contain lactic acid bacteria for healthy adults - |
| Date of disclosure of the study information | 2018/05/02 |
| Last modified on | 2020/10/09 11:16:37 |
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Basic information
Public title
The effect confirmation study of usual consumption of test food - a preliminary verification of the effect of the test food which contain lactic acid bacteria for healthy adults -
Acronym
The 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 - a preliminary verification of the effect of the test food which contain lactic acid bacteria for healthy adults -
Scientific Title:Acronym
The 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
Defecation frequency
Key secondary outcomes
Body Mass Index
Condition of facial skin
Microbiota of intestine
Productive availability of equol
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Preliminary test - the test before consumption of the test food - consumption of the usual amount of test food for 8 weeks and the test every week - the test after quit consumption of the test food.
Interventions/Control_2
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 | Toshio |
| 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
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
0532-32-3631
Homepage URL
technicalcenter@ichibiki.co.jp
Sponsor or person
Institute
Tokai Gakuen University
Institute
Department
Personal name
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
Research Ethics Committee of Tokai Gakuen University
Address
2-901 Nakahira, Tenpaku-ku, Nagoya-shi, Aichi 468-8514, Japan
Tel
052-801-1201
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
| 2018 | Year | 05 | Month | 02 | 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 | 04 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 05 | Month | 07 | 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
| 2018 | Year | 04 | Month | 27 | Day |
Last modified on
| 2020 | Year | 10 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036958
