UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052406 |
|---|---|
| Receipt number | R000059824 |
| Scientific Title | A study on the moderation effect of testing food on stress responses: Single blind test |
| Date of disclosure of the study information | 2024/03/31 |
| Last modified on | 2024/04/03 16:37:03 |
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Basic information
Public title
A study on the moderation effect of testing food on stress responses
Acronym
A study on the moderation effect of testing food on stress responses
Scientific Title
A study on the moderation effect of testing food on stress responses: Single blind test
Scientific Title:Acronym
A study on the moderation effect of testing food on stress responses: Single blind test
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the moderation effect of testing food on stress responses in healthy adults
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Stress responses (PANAS, IPANAT)
Key secondary outcomes
Salivary cortisol, salivary chromogranin, salivary oxytocin
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
A single intake of testing food
Interventions/Control_2
A single intake of placebo food
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1)Healthy male/female who are 18 years of age or older at the time of consent.
(2)Those who have signed a consent from prior to the start of the study upon full explanation of the purpose and content of the study.
Key exclusion criteria
(1)Those who have a citrus allergy.
(2)Those who are pregnant or breastfeeding or planning a pregnancy.
(3)Those who is taking medication or under medical treatment due to serious illness.
(4)Those who are deemed inappropriate for this study by the investigator.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Hashimoto |
Organization
Shizuoka University
Division name
Faculty of Humanities and Social Sciences
Zip code
422-8529
Address
836, Ohya, Suruga-ku, Shizuoka-Shi, Shizuoka-Ken, Japan
TEL
054-238-4917
hashimoto.takeshi.b@shizuoka.ac.jp
Public contact
Name of contact person
| 1st name | Masanori |
| Middle name | |
| Last name | Ozeki |
Organization
POKKA SAPPORO F&B Co., Ltd.
Division name
Research & Development Division, Fundamental Technology R&D Institute
Zip code
425-0013
Address
10 Okatohme, Yaizu-shi, Shizuoka, Japan
TEL
054-629-7982
Homepage URL
masanori.ozeki@pokkasapporo-fb.co.jp
Sponsor or person
Institute
POKKA SAPPORO F&B Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
POKKA SAPPORO F&B Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
POKKA SAPPORO F&B Co., Ltd. Research Ethics Committee
Address
4-20-1 Ebisu, Shibuya-ku, Tokyo, Japan
Tel
03-5795-1105
Toshihiro.Takahashi@pokkasapporo-fb.co.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
静岡大学(静岡県) /Shizuoka University (Shizuoka)
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 03 | Month | 31 | 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
| 2023 | Year | 09 | Month | 05 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 05 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2024 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2024 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 10 | Month | 04 | Day |
Last modified on
| 2024 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059824
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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