UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation test of changes in autonomic nervous activity by test-food intake in a single dose
Acronym	Evaluation test of changes in autonomic nervous activity by test-food intake in a single dose
Scientific Title	Evaluation test of changes in autonomic nervous activity by test-food intake in a single dose
Scientific Title:Acronym	Evaluation test of changes in autonomic nervous activity by test-food intake in a single dose
Region	Japan

Condition
Condition	Healthy male adults
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate whether test-food intakes can affect the autonomic nervous system
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Electronic pupillometer-measurement data
Key secondary outcomes	1. Electronic pupillometer-measurement data 2. Heart rate sensor-measurement data 3. Physiological measurement data 4. Questionnaire

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is 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	Consumption of the test liquid (200 mL) or the test food (4 drops with 200 mL water) to the subjects within 2 min.
Interventions/Control_2	Consumption of the placebo (200 mL water) to the subjects within 2 min.
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	50 years-old >
Gender	Male
Key inclusion criteria	(1) Healthy male subjects ranging in age from 20 to 49. (2) Subjects with less than 25.0 kg/m2 BMI. (3) No smoking subjects (over recent one year). (4) Subjects who gave informed consent to participate in this trial after being provided with an explanation of the protocol detail.
Key exclusion criteria	(1) Subjects with some kind of medical treatment continuously, combining the test period. (2) Subjects who have regularly used health-specific / functional / health foods, which might affect the autonomic nervous system, metabolism and sleep. (3) Subjects with incompatible eyeballs/eyelashes for pupillometry. (4) Subjects who have any difficulty in equipping a pulse-rate meter. (5) Subjects with excessive alcohol intake. (6) Subjects with extremely irregular life rhythms, and subjects with midnight work or irregular shift work. (7) Subjects who are now under the other clinical tests with some kind of medicine/food, or participated those tests within four weeks after the current trial. (8) Subjects who are under large stress condition with some kind of life event, such as house-moving, bereavement, etc., within three months before the agreement for this trial. (9) Subjects with difficulty in giving up drinking since the day before the scheduled date of this trial. (10) Subjects with previous and/or current medical history of serious diseases in heart, liver, kidney and/or digestive organs. (11) Subjects with previous medical history of drug and/or food allergy. (12) Others who have been determined as ineligible for participation, judging from the principal/sub investigator's opinions.
Target sample size	16

Research contact person
Name of lead principal investigator	1st name Suguru Middle name Last name Fujiwara
Organization	CPCC Company Limited
Division name	Division of Clinical Research
Zip code	101-0047
Address	4F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo 101-0047, Japan
TEL	03-5297-3112
Email	cpcc-contact@cpcc.co.jp

Public contact
Name of contact person	1st name Masanori Middle name Last name Numa
Organization	CPCC Company Limited
Division name	Planning & Sales Department
Zip code	101-0047
Address	4F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo 101-0047, Japan
TEL	03-5297-3112
Homepage URL
Email	cpcc-contact@cpcc.co.jp

Sponsor
Institute	Chiyoda Paramedical Care Clinic
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	Institutional Review Board of Chiyoda Paramedical Care Clinic
Address	2F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo 101-0047, Japan
Tel	03-5297-5548
Email	IRB@cpcc.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	2021 Year 06 Month 22 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	2020 Year 06 Month 22 Day
Date of IRB	2020 Year 06 Month 19 Day
Anticipated trial start date	2020 Year 06 Month 23 Day
Last follow-up date	2020 Year 07 Month 23 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 06 Month 22 Day
Last modified on	2021 Year 06 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046642