UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045471 |
|---|---|
| Receipt number | R000051889 |
| Scientific Title | Clinical Study to Investigate the Effect of the Functional Food on Improving Minor Health Complaints: An Open-Label, Uncontrolled Pilot Study |
| Date of disclosure of the study information | 2021/09/17 |
| Last modified on | 2022/06/01 16:04:36 |
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Basic information
Public title
Clinical Study to Investigate the Effect of the Functional Food on Improving Minor Health Complaints: An Open-Label, Uncontrolled Pilot Study
Acronym
NARO Style plus BENTO study
Scientific Title
Clinical Study to Investigate the Effect of the Functional Food on Improving Minor Health Complaints: An Open-Label, Uncontrolled Pilot Study
Scientific Title:Acronym
NARO Style plus BENTO study
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate improving minor health complaints associated with 8 weeks daily ingestion of the functional food, in an open-label, uncontrolled pilot study.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The Brief Job Stress Questionnaire (Section B) at 8weeks after beginning the intake of test food.
Key secondary outcomes
Blood pressure, pulse rate, body weight, BFP, basal metabolic rate, muscle mass, internal water content, BMI, survey on subjects' sleeping, bowel movement, mental and physical condition, sense of accomplishment, change of daily behavior
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
The subjects take the test food during 8weeks (5meals/ w and 1meal/ d).
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
Male and Female
Key inclusion criteria
1.Subjects with informed consent for the study participation.
2.Subjects with minor health complaints.
Key exclusion criteria
1.Subjects with implantable electronic medical devices.
2.Subjects who receive nourishment instruction.
3.Subjects who cannot take the test food during 8weeks because of allergy risk and so on.
4.Subjects whose lifestyle is expected to change significantly.
5.Subjects who currently participate in other clinical trials, or participated within the last 4 wks prior to the current study.
6.Any other medical and/or health reasons unfavorable to participation in the current study, as judged by the principal investigator.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Naoyuki |
| Middle name | |
| Last name | HONMA |
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
hisc-acad.res@s.do-johodai.ac.jp
Public contact
Name of contact person
| 1st name | Naoyuki |
| Middle name | |
| Last name | HONMA |
Organization
Hokkaido Information University
Division name
Health Information Science Center
Zip code
011-385-4430
Address
59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
TEL
011-385-4430
Homepage URL
hisc-acad.res@s.do-johodai.ac.jp
Sponsor or person
Institute
Hokkaido Information University
Institute
Department
Personal name
Funding Source
Organization
National Agriculture and Food Research Organization, bio-oriented technology Research Advancement Institution
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
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
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
| 2021 | Year | 09 | Month | 17 | 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
| 2021 | Year | 08 | Month | 27 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 27 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 24 | Day |
Last follow-up date
| 2022 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 09 | Month | 13 | Day |
Last modified on
| 2022 | Year | 06 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051889
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
