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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029811
Receipt No. 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

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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
Email 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
Email matsuoka@huma-c.co.jp

Sponsor
Institute Otsuka Pharmaceutical Co., Ltd.
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034044

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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