UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045751 |
|---|---|
| Receipt number | R000052203 |
| Scientific Title | Effect of Daily Ingestion of Test food on Improving Minor Health Complaints: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study |
| Date of disclosure of the study information | 2021/10/26 |
| Last modified on | 2023/04/17 10:01:51 |
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Basic information
Public title
Effect of Daily Ingestion of Test food on Improving Minor Health Complaints: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study
Acronym
Effect of Daily Ingestion of Test food on Improving Minor Health Complaints
Scientific Title
Effect of Daily Ingestion of Test food on Improving Minor Health Complaints: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study
Scientific Title:Acronym
Effect of Daily Ingestion of Test food on Improving Minor Health Complaints
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To prove improving minor health complaints and safety associated with 4 weeks daily ingestion of test food, in a double-blind, placebo-controlled, parallel group comparison study.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
POMS 2 full-length versions for adults after 4 weeks of ingestion.
Key secondary outcomes
Heart rate variability, electroencephalogram during sleeping, survey on subjects' sleeping and mental and physical conditions, sleeping record, blood oxidative stress markers, urinary 8-OHdG.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Daily ingestion 10 tablets of active test food for 4 weeks.
Interventions/Control_2
Daily ingestion 10 tablets of placebo test food 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
| 20 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Female
Key inclusion criteria
1. Subjects who agree to participate in this study with a written informed consent.
2. Subjects without serious cerebrovascular, cardiac, hepatic, renal, gastrointestinal diseases, and/or affected with infectious diseases requiring report to the authorities.
3. Workers.
4. Subjects with minor health complaints.
Key exclusion criteria
1. Subjects who are under physician's advice, treatment, and/or medication for schizophrenia, depression, mania, neurological disorders, sleep disorders and/or chronic fatigue syndrome.
2. Subjects with suspected depression.
3. Subjects with implantable electronic medical devices.
4. Subjects with major surgical history relevant to the digestive system such as gastrectomy, gastrorrhaphy, enterectomy, etc.
5. Subjects with unusually high and/or low blood pressure and/or abnormal body measurement data and/or abnormal hematological data.
6. Subjects whose BMI is <16 kg/m2 or >=30 kg/m2
7. Subjects with severe anemia.
8. Subjects who are at risk of having allergic reactions to 28 food allergic substances and/or materials of test food.
9. Heavy smokers, alcohol addicts or subjects with disordered lifestyle.
10. Pre- or post-menopausal women complaining of obvious physical changes.
11. Pregnant, lactating women or women who expect to be pregnant during this study.
12. Subjects who regularly take which contains materials of test foods.
13. Subjects who regularly take medicine, functional foods, and/or supplements which would affect sleep and/or stress.
14. Subjects who plan to travel abroad during this study.
15. Subjects whose lifestyle changed within a year prior to the current study.
16. Subjects whose lifestyle is expected to change.
17. 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, or subjects who do not agree not to donate blood during this study.
18. Subjects who currently participate in other clinical trials, or participated within the last 4 weeks prior to the current study, or intend to participate in order clinical trials after obtaining consent to participate in this study.
19. 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
011-385-4430
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
069-8585
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
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)
Meiji Co., Ltd.
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 | 10 | Month | 26 | 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 | 09 | Month | 22 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 22 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 25 | Day |
Last follow-up date
| 2022 | Year | 02 | Month | 26 | 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 | 10 | Month | 14 | Day |
Last modified on
| 2023 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052203
