UMIN-CTR Clinical Trial

Basic information
Public title	Relaxation effect confirmation test of test beverage-1
Acronym	Relaxation effect confirmation test of test beverage-1
Scientific Title	Relaxation effect confirmation test of test beverage
Scientific Title:Acronym	Relaxation effect confirmation test of test beverage
Region	Japan

Condition
Condition	Healthy subjects
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The relaxing effect of the test beverage will be examined for Japanese men and women between the ages of 20 and 35.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Heart rate sensor measurement data
Key secondary outcomes	(Secondary outcomes) Psychological evaluation questionnaire, flavor evaluation questionnaire. (Safety evaluation) Vital signs, physical measurements, adverse events.

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Take test beverage on the day of the test. Wash out Take placebo beverage on the day of the test.
Interventions/Control_2	Take placebo beverage on the day of the test. Wash out Take test beverage on the day of the test.
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	20 years-old <=
Age-upper limit	35 years-old >
Gender	Male and Female
Key inclusion criteria	1.Japanese male and female who are between 20 and 35 years old at the time of obtaining written consent. 2.Subject with BMI <25kg/m2. 3.Non-smokers (no smoking in the last year) 4.Subject who has received sufficient explanation of the purpose and content of the research, has the ability to consent.
Key exclusion criteria	1.Subject who is taking medication or under medical treatment due to illness. 2.Subject who is taking foods for specified health use, foods with functional claims, health foods (including supplements) that affect the autonomic nervous system, metabolism, and sleep, and cannot stop taking them during the test period. 3.Subject who is out of the hospital due to mental disorders (depression, etc.) or sleep disorders, or who has a history of mental illness in the past. 4.Subject with a history of serious diseases such as heart, liver, kidneys, digestive organs, brain, malignant tumors, immune diseases, diabetes, etc. 5.Subject who has problems with heart rate measurement (thick chest hair, using a pacemaker, rash on the skin, etc.) 6.Heavy drinker. 7.Subject who has difficulty quitting drinking from the day before the test date. 8.Subject who has extremely irregular eating habits, those who work shifts, those who work late at night, etc. 9.Subject who is participating in other clinical trials at the time of obtaining consent, and who plans to participate in other clinical trials within 4 weeks from the end of the study to the start of the main study of the study, or after consenting to participate in the study. 10.Subject who is likely to be under great stress due to moving, changing jobs, separation from close relatives, etc. within the last 3 months. 11.Subject who exercises violently on a daily basis. 12.Subject with severe PMS (premenstrual syndrome) symptoms. 13.Subject who is planning to get pregnant during the test period after the day of informed consent or is currently pregnant and lactating. 14.Subject with hay fever or allergic rhinitis (seasonal or perennial) 15.Subject who is allergic to medicines and food. 16.Subject who has or had a history of either medicine or alcohol. 17.Subject who can't keep the daily records. 18.Subject who the investigator has determined that participation in this study is inappropriate.
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Hidemasa Middle name Last name Toya
Organization	HUMA R&D CORP
Division name	Clinical Development Department
Zip code	108-0014
Address	Round Cross Tamachi 10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL	03-3431-1260
Email	toya@huma-rd.co.jp

Public contact
Name of contact person	1st name Hidemasa Middle name Last name Toya
Organization	HUMA R&D CORP
Division name	Clinical Development Department
Zip code	108-0014
Address	Round Cross Tamachi 10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL	03-3431-1260
Homepage URL
Email	toya@huma-rd.co.jp

Sponsor
Institute	HUMA R&D CORP
Institute
Department

Funding Source
Organization	Asahi Quality & Innovations, 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	Ethics Committees of Yoga Allergy Clinic
Address	4-32-16 Yoga,Setagaya-ku,Tokyo 158-0097 Japan
Tel	03-5491-4478
Email	jim@medipharma.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

Other administrative information
Date of disclosure of the study information	2022 Year 08 Month 15 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	40
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	2021 Year 08 Month 06 Day
Date of IRB	2021 Year 08 Month 13 Day
Anticipated trial start date	2021 Year 08 Month 16 Day
Last follow-up date	2021 Year 10 Month 07 Day
Date of closure to data entry	2021 Year 10 Month 21 Day
Date trial data considered complete	2021 Year 10 Month 27 Day
Date analysis concluded	2022 Year 10 Month 03 Day

Other
Other related information

Management information
Registered date	2021 Year 08 Month 13 Day
Last modified on	2022 Year 10 Month 05 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051568