UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048994 |
|---|---|
| Receipt number | R000055766 |
| Scientific Title | Investigation of the effect of KURAHANA yeast intake. |
| Date of disclosure of the study information | 2023/09/26 |
| Last modified on | 2024/03/27 09:18:22 |
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Basic information
Public title
Investigation of the effect of yeast intake in healthy people.
Acronym
Investigation of the effect of yeast intake in healthy people.
Scientific Title
Investigation of the effect of KURAHANA yeast intake.
Scientific Title:Acronym
Investigation of the effect of KURAHANA yeast intake.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Exploratory verification of efficacy when ingesting test food for a certain period of time.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
(1)Defecation score (property, frequency) [after 8 weeks of ingestion]
Key secondary outcomes
(1)Defecation score (property, frequency) [after 4 weeks of ingestion]
(2)Defecation status (experience, pain, score.) [after 4 and 8 weeks of ingestion]
(3)Sleep status, physical condition (stress, fatigue, skin quality, anemia, hay fever, menstruation) [after 4 and 8 weeks of ingestion]
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, 1 tablets a day, for eight continuous weeks.
Interventions/Control_2
Intake control food, 1 tablets a day, for eight 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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1)Healthy Japanese aged 18 to 65 years old when consent acquisition.
(2)Japanese who don't be given treatment by taking medicines, therapies and/or operations even seasonal, chronic or sudden case.
(3)Japanese 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)Japanese 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.
(5)Japanese whose pulses are 40 to 100 times per minute.
(6)Japanese whose body temperatures are 35.5 to 37.0 degrees Celsius.
(7)Japanese who basically take 3 meals a day and can prohibit drinking and eating too much(Includes overdose of alcohol, stimulants and caffeine).
(8)Japanese who can contraception properly during test period.
(9)Japanese who can understand and compliance to controlled matters.
(10) Japanese who can prohibit the intake of supplements and foods with functional claims.
Key exclusion criteria
(1) Japanese 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)Japanese who have surgery history in digestive tract such as gastrectomy, gastrointestinal suture surgery and/or intestinal resection etc., but except polypectomy and appendectomy.
(3)Japanese who have medical history of cerebral vascular disorder.
(4)Japanese who have specific constitution that occur allergy and/or hypersensitivity against test food.
(5) Japanese who suspect to alcohol dependence and/or drug dependence.
(6) Japanese who have attended other clinical trial and/or clinical study within 84 days before consent acquisition.
(7) Japanese who have done 400mL of whole blood donation within 84 days before consent acquisition. Japanese who have done 200mL of whole blood donation within 28 days before consent acquisition. Japanese who have done 200mL of ingredient donation within 14 days before consent acquisition.
(8)Japanese who are lactating and/or pregnant.
(9) Japanese who engage in mid-night work.
(10) Japanese who are on any medication (please report if medication is required during this clinical study).
(11) Japanese who taking contraceptive pills for any purpose.
Target sample size
64
Research contact person
Name of lead principal investigator
| 1st name | Tomomi |
| Middle name | |
| Last name | Kannno |
Organization
Aichi Shukutoku University.
Division name
Health and Medical Science
Zip code
480-1197
Address
2-9 Katahira, Nagakute, Aichi
TEL
0561-62-4111
kannot@asu.aasa.ac.jp
Public contact
Name of contact person
| 1st name | Noriyuki |
| Middle name | |
| Last name | Asai |
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
technicalcenter@ichibiki.co.jp
Sponsor or person
Institute
Aichi Shukutoku 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
Institutional Review Board of Aichi Shukutoku University Health and Medical Science
Address
2-9 Katahira, Nagakute, Aichi
Tel
0561-62-4111
kannot@asu.aasa.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
| 2023 | Year | 09 | Month | 26 | Day |
Related information
URL releasing protocol
unpublished
Publication of results
Unpublished
Result
URL related to results and publications
unpublished
Number of participants that the trial has enrolled
38
Results
a
Results date posted
| 2024 | Year | 03 | Month | 26 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Male/female = 3/35, average age 21.6 (18-38) years
Participant flow
Not applicable
Adverse events
none
Outcome measures
Defecation score (sexuality and frequency)
Defecation status (sensation, pain)
Sleep status, physical condition (stress, fatigue, skin quality, anemia, hay fever, menstruation)
Physical measurements (skeletal muscle mass, weight, etc.)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 09 | Month | 15 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 14 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 26 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 19 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 09 | Month | 21 | Day |
Last modified on
| 2024 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055766
