UMIN-CTR Clinical Trial

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
Email	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
Email	okamura_hisayoshi@med.kurume-u.ac.jp

Sponsor
Institute	Kurume University
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022919