UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044977 |
|---|---|
| Receipt number | R000051245 |
| Scientific Title | Evaluation research about variations in autonomic nervous activity by test-food intake in a single dose |
| Date of disclosure of the study information | 2022/07/31 |
| Last modified on | 2023/01/30 10:14:18 |
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Basic information
Public title
Evaluation research about variations in autonomic nervous activity by test-food intake in a single dose
Acronym
Evaluation research about variations in autonomic nervous activity by test-food intake in a single dose
Scientific Title
Evaluation research about variations in autonomic nervous activity by test-food intake in a single dose
Scientific Title:Acronym
Evaluation research about variations in autonomic nervous activity by test-food intake in a single dose
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 evaluate changes in autonomic nervous activity by 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
Heartbeat
Key secondary outcomes
1. Psychological questionnaire
2. Flavor-evaluating questionnaire
3. Body surface temperature
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
Ingestion of the test liquid (200 mL) to the subjects within 5 min or 15 min.
Interventions/Control_2
Ingestion of the placebo (200 mL water) to the subjects within 5 min or 15 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) Healthy 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, 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) Subjects having any difficulty in touching alcoholic drinks constitutionally.
(13) Pregnant, possibly pregnant, and lactating women.
(14) Subjects having some kind of drug and/or food allergy.
(15) Others who have been determined as ineligible for participation, judging from the principal/sub investigator's opinions.
Target sample size
40
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
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
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 Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo 101-0047, Japan
Tel
03-5297-5548
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 | 07 | Month | 31 | 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 | 07 | Month | 20 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 16 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 31 | Day |
Last follow-up date
| 2021 | Year | 09 | Month | 24 | 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 | 07 | Month | 28 | Day |
Last modified on
| 2023 | Year | 01 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051245
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