UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049341 |
|---|---|
| Receipt number | R000056042 |
| Scientific Title | Validation of changes in autonomic nervous activity by a test-material consumption |
| Date of disclosure of the study information | 2023/11/01 |
| Last modified on | 2023/08/21 12:13:43 |
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Basic information
Public title
Validation of changes in autonomic nervous activity by a test-material consumption
Acronym
Validation of changes in autonomic nervous activity by a test-material consumption
Scientific Title
Validation of changes in autonomic nervous activity by a test-material consumption
Scientific Title:Acronym
Validation of changes in autonomic nervous activity by a test-material consumption
Region
| Japan |
Condition
Condition
Healthy male/female adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm some kind of effect by the test-material intake, on the autonomic nervous system.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pupil measurement
Key secondary outcomes
1. Psychological questionnaire
2. Skin temperature
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Having a smell of the test liquid (100 mL) to the subjects for 2 min.
Interventions/Control_2
Savoring the taste of the test liquid (30 mL) to the subjects for 1 min, and throwing it up.
Interventions/Control_3
Having a smell of the placebo liquid (100 mL) to the subjects for 2 min.
Interventions/Control_4
Savoring the taste of the placebo liquid (30 mL) to the subjects for 1 min, and throwing it up.
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 take part in this trial, after being provided with an explanation of the protocol detail.
Key exclusion criteria
(1) Subjects being under some kind of continuous medical treatment.
(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 eyeballs/eyelashes for pupillometry.
(4) Subjects with any hindrances to a pupil measurement (e.g., dry eye).
(5) Subjects having a subjective symptom of claustrophobia and nyctophobia.
(6) Subjects with nasal congestion and wrong judgement of fragrance.
(7) Subjects with excessive alcohol intake (not less than 60 g/day/week).
(8) Subjects with extremely irregular eating habits, and subjects having an irregular life rhythm with irregular shift work or midnight one.
(9) At the moment of informed consent, subjects who are under other clinical trials with some kind of medicine/food, or partook in those within four weeks before this trial.
(10) 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.
(11) Subjects with previous and/or current medical history of serious diseases in heart, liver, kidney and/or digestive organs.
(12) Subjects with a serious symptom of premenstrual syndrome at the moment of this trial.
(13) Subjects who vaccinated within three days before this trial.
(14) Pregnant, possibly pregnant, and lactating women.
(15) Subjects having some kind of drug and/or food allergy.
(16) Others who have been determined as ineligible for participation, judging from the principal/sub investigator's opinions.
Target sample size
24
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
103-0021
Address
4F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan
TEL
03-6225-9001
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
103-0021
Address
4F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan
TEL
03-6225-9001
Homepage URL
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
CPCC Company Limited
Institute
Department
Personal name
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 Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan
Tel
03-6225-9005
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
| 2023 | Year | 11 | Month | 01 | 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
24
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
| 2022 | Year | 10 | Month | 24 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 21 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 11 | Month | 02 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 10 | Month | 27 | Day |
Last modified on
| 2023 | Year | 08 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056042
