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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000038874
Receipt No. R000044331
Scientific Title Effect of Daily Intake of Active Test Food on stress-reducing: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Comparison Study
Date of disclosure of the study information 2019/12/13
Last modified on 2020/03/16

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Basic information
Public title Effect of Daily Intake of Active Test Food on stress-reducing: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Comparison Study
Acronym Effect of Daily Intake of Active Test Food on stress-reducing
Scientific Title Effect of Daily Intake of Active Test Food on stress-reducing: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Comparison Study
Scientific Title:Acronym Effect of Daily Intake of Active Test Food on stress-reducing
Region
Japan

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

Objectives
Narrative objectives1 To prove clinical benefits associated with 2 weeks daily intake of active test food on stress-reducing.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Heart rate variability at 2 weeks after beginning the ingestion of test food.
Key secondary outcomes Electroencephalogram during sleeping, sleeping record, gut flora, blood metabolome, salivary amylase, questionnaire about subjects' background information, VAS questionnaire assessed stress.

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 No need to know

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Daily intake of 0.9 g of active test food for 2 weeks.
Interventions/Control_2 Daily intake of 0.9 g of placebo test food for 2 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 Male and Female
Key inclusion criteria 1. Subjects who agree to participate in this study with a written informed consent.
2. Subjects who are feeling stress.
3. Subjects who show relatively low score of Brief Job Stress Questionnaire (BJSQ).
4. Subjects who show relatively low score of VAS questionnaire assessed stress.
5. Subjects who show relatively high score of heart rate variability (Ratio of LF to HF).
Key exclusion criteria 1. Subjects who are under physician's advice, treatment, and/or medication for schizophrenia, depressive disorder, mania neurologic disorder, sleeping disorder, and/or diabetes.
2. Subjects who regularly take anticoagulant, antiplatelet medicine, and/or NSAIDs.
3. Subjects with serious cerebrovascular, cardiac, hepatic, renal, gastrointestinal diseases, and/or affected with infectious diseases requiring reports to the authorities.
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 hematological data.
6. Subjects with severe anemia.
7. Pre- or post-menopausal women complaining of obvious physical changes.
8. Subjects who are at risk of having allergic reactions to drugs or foods especially based on materials of test food and/or soybean.
9. Subjects who regularly take functional foods, and/or supplements which affect sleep and/or stress.
10. Subjects who regularly take drugs which affect bowel movements.
11. Subjects who have used as needed or continued to use antibiotics within 12 weeks prior to the current study.
12. Subjects who have a habit of taking material of test food over 200 g/day.
13. Heavy smokers, alcohol addicts or subjects with disordered lifestyle.
14. 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.
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 Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Bioresource and Bioenvironment Kyushu University
Name of secondary funder(s) Nisshin Seifun Group Inc.

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

Other administrative information
Date of disclosure of the study information
2019 Year 12 Month 13 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 No longer recruiting
Date of protocol fixation
2019 Year 10 Month 28 Day
Date of IRB
2019 Year 10 Month 28 Day
Anticipated trial start date
2019 Year 12 Month 14 Day
Last follow-up date
2020 Year 02 Month 22 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 12 Month 13 Day
Last modified on
2020 Year 03 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044331

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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