UMIN-CTR Clinical Trial

Basic information
Public title	Validation of effects by taking a single dose of test food, on brain waves and autonomic nervous system
Acronym	Validation of effects by taking a single dose of test food, on brain waves and autonomic nervous system
Scientific Title	Validation of effects by taking a single dose of test food, on brain waves and autonomic nervous system
Scientific Title:Acronym	Validation of effects by taking a single dose of test food, on brain waves and autonomic nervous system
Region	Japan

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

Objectives
Narrative objectives1	In order to verify some kind of effect on brain waves and the autonomic nervous system, by the test-food intake in a single dose
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Brain waves
Key secondary outcomes	1. Heartbeat 2. Cerebral stress 3. Cerebral fatigue 4. Psychological questionnaire 5. Flavor-evaluating questionnaire 6. Subjective vitality scale (Japanese ver.)

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	Consumption of the test liquid (200 mL) to the subjects within 5 min.
Interventions/Control_2	Consumption of the placebo liquid (200 mL) to the subjects within 5 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	35 years-old >
Gender	Male and Female
Key inclusion criteria	(1) Male/female subjects ranging in age from 20 to 34 at informed consent. (2) Subjects having less than 25.0 kg/m2 of BMI. (3) Subjects with no smoking (not less than one year). (4) Subjects who can give informed consent to participate in this study, after being provided with an explanation of the protocol detail.
Key exclusion criteria	(1) Subjects being under some kind of continuous medical treatment, including the test period. (2) Subjects who have periodically used health-specific / functional / health foods including supplements, which might affect the autonomic nervous system, metabolism and sleep. (3) Subjects with incompatible chest (e.g., thick bodyhair, pacemaker-fitting) for heartbeat measurements. (4) Subjects with excessive alcohol intake (not less than 60 g/day/week). (5) Subjects with extremely irregular eating habits, and subjects having an irregular life rhythm with irregular shift work or midnight one. (6) At the moment of informed consent, subjects who are under the other clinical tests with some kind of medicine/food, or participated in those within four weeks after the current trial, or are planning to join those after the consent. (7) Subjects who are under a large stress condition with some kind of life event, such as house-moving, transfer, bereavement, etc., within three months before the agreement for this trial and during the test period. (8) Subjects with any difficulty in giving up drinking since the day before the scheduled date of this trial. (9) Subjects with previous and/or current medical history of serious diseases in heart, liver, kidney and/or digestive organs. (10) Subjects getting excessive exercise every day. (11) Subjects with a serious symptom of premenstrual syndrome. (12) Pregnant, possibly pregnant, and lactating women. (13) Subjects having some kind of drug and/or food allergy. (14) Others who have been determined as ineligible for participation, judging from the principal/sub investigator's opinions.
Target sample size	27

Research contact person
Name of lead principal investigator	1st name Fumiko Middle name Last name Nakamura
Organization	CPCC Company Limited
Division name	Clinical Support 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
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	Clinical Planning 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	CPCC Company Limited
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	2022 Year 10 Month 05 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	2021 Year 09 Month 21 Day
Date of IRB	2021 Year 09 Month 17 Day
Anticipated trial start date	2021 Year 10 Month 06 Day
Last follow-up date	2021 Year 11 Month 26 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 10 Month 01 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=R000052032