UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056441 |
|---|---|
| Receipt number | R000064498 |
| Scientific Title | Effect of the test beverage intake on stress and tension in healthy adult |
| Date of disclosure of the study information | 2024/12/13 |
| Last modified on | 2026/02/02 14:57:45 |
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Basic information
Public title
Effect of the test beverage intake on stress and tension in healthy adult
Acronym
Effect of the test beverage intake on stress and tension in healthy adult
Scientific Title
Effect of the test beverage intake on stress and tension in healthy adult
Scientific Title:Acronym
Effect of the test beverage intake on stress and tension in healthy adult
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of the test beverage on stress and tension
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Profile of Mood States 2nd Edition-Adult Short (T score of TA)
Key secondary outcomes
Profile of Mood States 2nd Edition-Adult Short (T scores of other scales)
VAS (fatigue, tension, stress)
Cortisol level in saliva,
Chromogranin A level in saliva
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of control beverage (single ingestion) - washout period - Intake of test beverage (single ingestion)
Interventions/Control_2
Intake of test beverage (single ingestion) - washout period - Intake of control beverage (single ingestion)
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
| 50 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Healthy males and females from 30 to 49 years of age
2. BMI less than 30 kg/m2 at the time of pre-examination
3. Participants who are aware that they are prone to stress and tension in their daily lives
4. Participants with elevated T-scores of TA (tension-anxiety) on the POMS2-AS at the time of pre-examination
5. Participants who fully understand the purpose and content of the research and agree to participate in the research of their own free will
Key exclusion criteria
1. Participants who do not like the aroma and taste of teas
2. Participants receiving treatment related to sleep, stress, and fatigue
3. Participants who consume functional foods and other health foods related to sleep, stress, fatigue, and tension at least a day per week
4. Participants who are being treated for, have a history of, or are suspected of having a mental disorder
5. Participants determined to have a major depressive episode
6. Participants who diagnosed or suspected as sleep apnea syndrome
7. Participants who have been diagnosed with insomnia
8. Participants who have been diagnosed with chronic fatigue syndrome
9. Heavy alcohol drinkers (60 g/day as alcohol content)
10. Participants with a smoking habit (except those who have been smoke-free for more than 6 months)
11. Participants with irregular life rhythms
12. Participants engaged in physical labor
13. Participants who have problems or diseases with bleeding in the oral
14. Participants undergoing dental treatment or hospital visits
15. Participants who have participated in a study with stress test
16. Participants having possibilities for emerging allergy
17. Participants who have disease that requires constant medication
18. Participants who regularly use medicines (including traditional chinese medicines), or have a serious medical history that requires medication
19. Participants whose physical measurements, physical examination values, and clinical examination values at the time of pre-examination are significantly out of the reference range
20. Participants who have participated in another study within a month prior to the present study, or who plan to participate in other studies
21. Participants who plan to become pregnant or breastfeed
22. Participants who are judged to be unsuitable as subjects based on the answers to the background survey
23. Participants who are judged as unsuitable for the study by the principal investigator for other reason
Target sample size
26
Research contact person
Name of lead principal investigator
| 1st name | Chika |
| Middle name | |
| Last name | Tagata |
Organization
ITO EN, Ltd.
Division name
Central Research Institute
Zip code
421-0516
Address
21 Mekami, Makinohara-shi, Shizuoka, Japan
TEL
0548-54-1247
chika-yokoyama@itoen.co.jp
Public contact
Name of contact person
| 1st name | Hiroyasu |
| Middle name | |
| Last name | Shimada |
Organization
EP Mediate Co., Ltd.
Division name
Development Department Trial Planning Section
Zip code
162-0821
Address
Kagurazaka AK Bldg., 1-8 Tsukudocho, Shinjuku-ku, Tokyo
TEL
090-5219-2774
Homepage URL
shimada.hiroyasu767@eps.co.jp
Sponsor or person
Institute
EP Mediate Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
ITO EN, Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Station Clinic Research Ethics Committee
Address
3-12-8, Takaban, Meguro-ku, Tokyo
Tel
03-6452-2712
nakajima.megumi888@eps.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
社会福祉法人新栄会 滝野川病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2024 | 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
26
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
| 2024 | Year | 12 | Month | 12 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 12 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 13 | Day |
Last follow-up date
| 2025 | Year | 02 | Month | 17 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 12 | Month | 12 | Day |
Last modified on
| 2026 | Year | 02 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064498
