UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028610 |
|---|---|
| Receipt number | R000032749 |
| Scientific Title | Investigation of psychological and physiological effects by drinking of the carbonated soft drink |
| Date of disclosure of the study information | 2017/08/09 |
| Last modified on | 2020/10/06 09:15:12 |
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Basic information
Public title
Investigation of psychological and physiological effects by drinking of the carbonated soft drink
Acronym
Investigation of psychological and physiological effects by drinking of the carbonated soft drink
Scientific Title
Investigation of psychological and physiological effects by drinking of the carbonated soft drink
Scientific Title:Acronym
Investigation of psychological and physiological effects by drinking of the carbonated soft drink
Region
| Japan |
Condition
Condition
Healthy women
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Scientific verification of effects of the carbonated soft drink consumption to mind and body.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1.Evaluation of autonomic nervous system
2.Evaluation of parasympathetic nervous system
Key secondary outcomes
1. A self-report instrument to measure multiple mood states
2. Visual analogue scale questionnaires of feeling
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
At rest testing.-Consumption of control food, then testing.-Consumption of test food, then testing.
Interventions/Control_2
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
| 30 | years-old | <= |
Age-upper limit
| 45 | years-old | >= |
Gender
Female
Key inclusion criteria
1. Females aged 30 to 45 years old who live near Tokyo.
2. Subjects who don't come with their child or children on the day of clinical test.
3. Subjects who show understanding of the clinical study procedures and agreement with participating the study by written informed consent prior to the study.
4. Subjects who aren't bad at carbonated soft drinks.
5. Subjects who don't request disclosing of individual test results.
Key exclusion criteria
1. Subjects who have smoking habit.
2. Subjects who are cold-sensitive constitution. (including subjects like that who feel cold on their hands and foots even in summer)
3. Subjects who are currently receiving medication due to treatment of disease.
4. In a past month, subjects who have had custom of taking or applying medicine for the treatment of diseases.
5. Subjects who have previous and/or current medical history of serious disease in liver, kidney, heart, lung and/or blood.
6. Subjects who drink alcohol a lot.
7. Subjects who are aware their menopause symptom.
8. Pregnant or expected pregnant, or lactating women.
9. Subjects who have symptom of dermatologic disease such as atopic dermatitis.
10. Subjects who have undergone surgery on investigation objective portion within the past 6 months.
11. Subjects who are participating the other clinical tests of medicines or foods. Subjects who participated other clinical tests of medicines or foods within a month prior to the current study.
12. Subjects who themselves and/or their family are working for a company that develops and/or manufactures beverages.
13. Subjects who feel uncomfortable after taking nearly 600 mL of drinks within 30 min.
14. Others those are determined ineligible by investigator.
Target sample size
17
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | |
| Last name | Sato |
Organization
Products Research & Development Laboratory, Research & Development Headquarters
Division name
Products Research & Development Laboratory, Research & Development Headquarters
Zip code
302-0106
Address
1-21, MIDORI 1-CHOME, MORIYA-SHI,IBARAKI
TEL
0297-46-1531
hiroaki.sato@asahiinryo.co.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Ichinohe |
Organization
CPCC Company Limited
Division name
Planning & Sales Department
Zip code
101-0047
Address
4F Chusin Building, 3-3-5 Uchikanda 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 SOFT DRINKS 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
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Chushin Building, 3-3-5 Uchikanda 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
| 2017 | Year | 08 | Month | 09 | 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 | 06 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 07 | Month | 24 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 08 | Month | 09 | Day |
Last modified on
| 2020 | Year | 10 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032749
