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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000042845
Receipt No. R000048897
Scientific Title Effect of Daily Ingestion of Test Food on Improving Physical-mental Minor Complaints: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study
Date of disclosure of the study information 2020/12/25
Last modified on 2021/04/15

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Basic information
Public title Effect of Daily Ingestion of Test Food on Improving Physical-mental Minor Complaints: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study
Acronym Effect of Daily Ingestion of Test Food on Improving Physical-mental Minor Complaints
Scientific Title Effect of Daily Ingestion of Test 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 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 food on improving physical-mental minor complaints.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Improving physical-mental minor complaints after 4 weeks of ingestion.
Key secondary outcomes Heart rate variability, electroencephalogram during sleeping, sleeping record, biomarkers in saliva (chromogranin A, IgA), VAS questionnaire on fatigue and stress, 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 30 g of active test food for 4 weeks.
Interventions/Control_2 Daily ingestion 30 g 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
65 years-old >
Gender Male and Female
Key inclusion criteria 1. Subjects who agree to participate in this study with a written informed consent.
2. Subjects who are aware of their fatigue on a daily basis.
3. Subjects with physical-mental minor complaints.
Key exclusion criteria 1. Subjects who are under physician's advice, treatment, and/or medication for schizophrenia, depression, mania, neurological disorders, and/or sleep disorders.
2. Subjects with serious cerebrovascular, cardiac, hepatic, renal, gastrointestinal diseases, and/or affected with infectious diseases requiring reports to the authorities.
3. Subjects with major surgical history relevant to the digestive system such as gastrectomy, gastrorrhaphy, enterectomy, etc.
4. Subjects with unusually high and/or low blood pressure, abnormal physical data and/or abnormal hematological data.
5. Subjects with severe anemia.
6. Pre- or post-menopausal women complaining of obvious physical changes.
7. Subjects who are at risk of having allergic reactions to drugs and/or foods especially citrus fruits.
8. Subjects who regularly take medicine, functional foods, and/or supplements which would affect fatigue.
9. Subjects who regularly take citrus fruits, citrus juices and/or umeboshi (Japanese pickled plums).
10. Heavy smokers, alcohol addicts and/or subjects with disordered lifestyle.
11. Subjects who donated either 400 ml whole blood within 16 weeks (women), 12 weeks (men), 200 ml whole blood within 4 weeks (men and women), or blood components within 2 weeks (men and women), prior to the current study.
12. Pregnant or lactating women or women who expect to be pregnant during this study.
13. Subjects who currently participate in other clinical trials, or participated within the last 4 weeks prior to the current study.
14. Any other medical and/or health reasons unfavorable to participation in the current study, as judged by the principal investigator.
Target sample size 24

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 Bioresource and Bioenvironment Kyushu University
Name of secondary funder(s) POKKA SAPPORO FoodOOD & BeverageEVERAGE LtdTD.

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 12 Month 25 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
2020 Year 11 Month 09 Day
Date of IRB
2020 Year 11 Month 09 Day
Anticipated trial start date
2021 Year 01 Month 19 Day
Last follow-up date
2021 Year 03 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 12 Month 25 Day
Last modified on
2021 Year 04 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048897

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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