UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029811 |
|---|---|
| Receipt number | R000034044 |
| Scientific Title | Examination of the effects of PD intake on autonomic nervous function in healthy adults: A Randomized, Double-blind, Placebo-controlled, Crossover Study. |
| Date of disclosure of the study information | 2018/12/16 |
| Last modified on | 2019/06/04 09:53:57 |
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Basic information
Public title
Examination of the effects of PD intake on autonomic nervous function in healthy adults: A Randomized, Double-blind, Placebo-controlled, Crossover Study.
Acronym
The effects of PD intake on autonomic nervous function
Scientific Title
Examination of the effects of PD intake on autonomic nervous function in healthy adults: A Randomized, Double-blind, Placebo-controlled, Crossover Study.
Scientific Title:Acronym
The effects of PD intake on autonomic nervous function
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of PD intake on autonomic nervous function and endocrine function during resting state and during stress load
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Autonomic nervous function during stress load
Key secondary outcomes
Autonomic nervous function and endocrine function during resting state
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
Intake test drink (PD) for 8 days, and take wash out period for 6 days, and then, intake placebo drink for 8 days.
Interventions/Control_2
Intake placebo drink for 8 days, and take wash out period for 6 days, and then, intake test drink (PD) for 8 days.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy males and females aged 20 years old or more.
Key exclusion criteria
1) Subjects who have allergic reaction to drug or food.
2) Subjects who have a severe past medical history, acute infection, mental disorder, serious complications or need emergency medical care.
3) Subjects who are under treatment for insomnia, sleep disorder, dysautonomia or endocrine disease.
4) Subjects who expected big change in living environment from 1 month before this study to the end of the study.
5) Subjects who donated either 400 mL whole blood within 12 weeks or 200 mL whole blood within 4 weeks or blood components within 2 weeks prior to this study.
6) Subjects who get an intense exercise.
7) Subjects who are heavy smokers (more than 20 cigarettes per day).
8) Subjects who are alcohol addicts.
9) Subjects who take a drink with high content of caffeine excessively.
10) Subjects who regularly take a drink with high content of theanine.
11) Subjects who have an extremely irregular eating pattern and work the shift or work on midnight.
12) Subjects who are pregnant, lactating or expected to be pregnant during the study.
13) Subjects who regularly take medicine, food for specified health uses, foods with function claims and / or health food which would affect the result of the study.
14) Subjects who are participating in other clinical trials or have participated in other clinical trials within 4 weeks prior to the study.
15) Subjects who have difficulty in compliance with recording of various surveys.
16) Subjects who are judged as unsuitable for the study by the principal investigator for other reasons.
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | Shoichiro |
| Middle name | |
| Last name | Inoue |
Organization
Otsuka Pharmaceutical Co., Ltd.
Division name
Otsu Nutraceuticals Research Institute
Zip code
520-0002
Address
3-31-13 Saigawa, Otsu, Shiga 520-0002, Japan
TEL
077-521-8835
inoue.shoichiro@otsuka.jp
Public contact
Name of contact person
| 1st name | Masao |
| Middle name | |
| Last name | Matsuoka |
Organization
HUMA R&D CORP
Division name
Clinical Development Division
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
matsuoka@huma-c.co.jp
Sponsor or person
Institute
Otsuka Pharmaceutical Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Otsuka Pharmaceutical Co., 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 Nihonbashi Egawa Clinic
Address
2F Kotobuki Build. 1-1-3 Yaesu Chuo-ku, Tokyo 103-0028 Japan
Tel
03-5204-0311
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
| 2018 | Year | 12 | Month | 16 | 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
| 2017 | Year | 10 | Month | 27 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 27 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 04 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 22 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 11 | Month | 02 | Day |
Last modified on
| 2019 | Year | 06 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034044
