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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042404
Receipt No. R000048404
Scientific Title Effect of Daily Ingestion of test beverage containing extract of koji-fermented food on improving physical-mental minor complaints: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study
Date of disclosure of the study information 2020/11/10
Last modified on 2020/11/10

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Basic information
Public title Effect of Daily Ingestion of test beverage containing extract of koji-fermented food on improving physical-mental minor complaints: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study
Acronym Effect of Daily Ingestion of test beverage containing extract of koji-fermented food on improving physical-mental minor complaints
Scientific Title Effect of Daily Ingestion of test beverage containing extract of koji-fermented food on improving physical-mental minor complaints: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study
Scientific Title:Acronym Effect of Daily Ingestion of test beverage containing extract of koji-fermented food on improving physical-mental minor complaints
Region
Japan

Condition
Condition Healthy Adult
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Comprehensive search for clinical benefits associated with 4 weeks daily intake of test beverage containing extract of koji-fermented food on improving physical-mental minor complaints.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes VAS questionnaire after 4 weeks of intake of test beverage
Key secondary outcomes Heart rate variability, electroencephalogram during sleeping, sleeping record, survey on subjects' sleeping and mental and physical conditions

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 NO
Institution consideration
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Daily ingestion 170 ml of test beverage containing extract of koji-fermented food for 4 weeks.
Interventions/Control_2 Daily ingestion 170 ml of placebo beverage for 4 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
30 years-old <=
Age-upper limit
65 years-old >
Gender Female
Key inclusion criteria 1. Subjects who agree to participate in this study with a written informed consent.
2. Subjects with physical-mental minor complaints.
Key exclusion criteria 1. Subjects with a clinical history of gastrointestinal cancer or currently under treatment or anti-tumor medication.
2. Subjects with gastrointestinal disorders such as inflammatory bowel syndrome, irritable bowel syndrome, etc.
3. Subjects under iron reduction therapy.
4. Subjects with serious cerebrovascular, cardiac, hepatic, renal, gastrointestinal diseases, and/or affected with infectious diseases requiring reports to the authorities.
5. Subjects with major surgical history relevant to the digestive system such as gastrectomy, gastrorrhaphy, enterectomy, etc.
6. Subjects with unusually high and/or low blood pressure, abnormal physical data and/or abnormal hematological data.
7. Subjects with severe anemia.
8. Pre- or post-menopausal women complaining of obvious physical changes.
9. Subjects who are at risk of having allergic reactions to drugs and/or foods especially koji.
10. Subjects who regularly take medicine, functional foods, and/or supplements which would affect bowel movements or intestinal environment.
11. Subjects who regularly take functional foods and/or supplements containg iron.
12. Subjects who regularly take koji and/or amazake 100 g/day.
13. Heavy smokers, alcohol addicts and/or subjects with disordered lifestyle.
14. Subjects who donated either 400 ml whole blood within 16 weeks, 200 ml whole blood within 4 weeks, or blood components within 2 weeks , prior to the current study.
15. Pregnant or lactating women or women who expect to be pregnant during this study.
16. Subjects who currently participate in other clinical trials, or participated within the last 4 weeks prior to the current study.
17. Any other medical and/or health reasons unfavorable to participation in the current study, as judged by the principal investigator.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Jun
Middle name
Last name NISHIHIRA
Organization Hokkaido Information University
Division name Department of Medical Management and Informatics
Zip code 069-8585
Address 59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
TEL 011-385-4411
Email nishihira@do-johodai.ac.jp

Public contact
Name of contact person
1st name Jun
Middle name
Last name NISHIHIRA
Organization Hokkaido Information University
Division name Health Information Science Center
Zip code 069-8585
Address 59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
TEL 011-385-4430
Homepage URL
Email nishihira@do-johodai.ac.jp

Sponsor
Institute Hokkaido Information University
Institute
Department

Funding Source
Organization National Agriculture and Food Research Organization
Organization
Division
Category of Funding Organization Government offices of other countries
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor National Agriculture and Food Research Organization
Name of secondary funder(s)

IRB Contact (For public release)
Organization The ethics committee of Hokkaido Information University
Address 59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
Tel 011-385-4411
Email soumu@do-johodai.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 北海道情報大学 保健センター(北海道)

Other administrative information
Date of disclosure of the study information
2020 Year 11 Month 10 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 Preinitiation
Date of protocol fixation
2020 Year 10 Month 28 Day
Date of IRB
2020 Year 10 Month 28 Day
Anticipated trial start date
2020 Year 11 Month 10 Day
Last follow-up date
2021 Year 02 Month 24 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 11 Month 10 Day
Last modified on
2020 Year 11 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048404

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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