UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019839 |
|---|---|
| Receipt number | R000022919 |
| Scientific Title | Verification test of anti-stress effects in humans by a single time intake of Asteraceous plant extracts -Main test- |
| Date of disclosure of the study information | 2015/11/18 |
| Last modified on | 2022/05/26 14:20:48 |
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Basic information
Public title
Verification test of anti-stress effects in humans by a single time intake of Asteraceous plant extracts -Main test-
Acronym
Verification test of anti-stress effects in humans by a single time intake of Asteraceous plant extracts -Main test-
Scientific Title
Verification test of anti-stress effects in humans by a single time intake of Asteraceous plant extracts -Main test-
Scientific Title:Acronym
Verification test of anti-stress effects in humans by a single time intake of Asteraceous plant extracts -Main test-
Region
| Japan |
Condition
Condition
N/A
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Confirm anti-stress effects and safety of a single time intake of Asteraceous plant extracts
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
cortisol in saliva, free-MHPG( final metabolites of central noradrenaline), s-IgA density and VAS
Key secondary outcomes
heartbeat, blood pressure
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
4
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Beverage blended with Asteraceous plant extracts(20mg)
Interventions/Control_2
Beverage blended with Asteraceous plant extracts(200mg)
Interventions/Control_3
Theanine-blended beverage
Interventions/Control_4
Beverage which contains neither Asteraceous plant extracts nor theanine
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
| 30 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1)Men and women between the ages of 20 and 29
(2 )Those who get a detailed briefing on this project in advance, can understand the contents, agree with its purpose, and can submit a written consent
Key exclusion criteria
(1) Those who take health assistant foods or supplements on a daily basis
(2) Those who take medicaments or healthy foods regularly, which could influence the test results
(3) Those who are receiving a medical treatment which might affect test results (psychosomatic medicine/neurology/neuropathic internal medicine etc.)
(4) Those who have a medical history of allergic diseases (seasonal allergic rhinitis= pollinosis/chronic allergic rhinitis/asthma/atopic dermatitis/allergic conjunctivitis)
(5) Those who have bleeding teeth or any other oral cavity problems
(6) Heavy drinkers/ Heavy smokers and those who drink caffeinated drinks in large quantities
(7) Those whose eating habits are extremely irregular/ Night-shift workers/ Those who work in shifts
(8) Those who are judged as inadequate to participate this study by doctors in charge
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Tsuda |
Organization
Kurume University
Division name
Department of Psychology
Zip code
839-0851
Address
1635 Mii-machi, Kurume-shi, Fukuoka-ken 839-0851 Japan
TEL
0942-43-4411
tsuda_akira@kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | Hisayoshi |
| Middle name | |
| Last name | Okamura |
Organization
Kurume University
Division name
Cognitive and Molecular Research Institute of Brain Diseases
Zip code
830-0011
Address
67 Asahi-machi, Kurume, Fukuoka, 830-0011 Japan
TEL
0942-31-7581
Homepage URL
okamura_hisayoshi@med.kurume-u.ac.jp
Sponsor or person
Institute
Kurume University
Institute
Department
Personal name
Funding Source
Organization
Suntory Beverage & Food Limited
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Beppu University/ Kyoto Tachibana University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Industry-academia-government collaboration promotion office
Address
67 Asahi-machi, Kurume, Fukuoka,
Tel
0942-31-7917
sangaku@kurume-u.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
| 2015 | Year | 11 | Month | 18 | 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
| 2015 | Year | 11 | Month | 12 | Day |
Date of IRB
| 2016 | Year | 02 | Month | 22 | Day |
Anticipated trial start date
| 2015 | Year | 11 | Month | 18 | Day |
Last follow-up date
| 2019 | Year | 05 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 11 | Month | 18 | Day |
Last modified on
| 2022 | Year | 05 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022919
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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