UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038249 |
|---|---|
| Receipt number | R000043583 |
| Scientific Title | Evaluation of the efficacy of test food on blood flow improvement |
| Date of disclosure of the study information | 2019/10/20 |
| Last modified on | 2020/10/09 10:27:27 |
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Basic information
Public title
Evaluation of the efficacy of test food on blood flow improvement
Acronym
Evaluation of the efficacy of test food on blood flow improvement
Scientific Title
Evaluation of the efficacy of test food on blood flow improvement
Scientific Title:Acronym
Evaluation of the efficacy of test food on blood flow improvement
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of single-consumption of the test food on blood flow improvement.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood flow
Key secondary outcomes
Skin surface temperature
Core body temperature
VAS for feeling of cold
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
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Taking a placebo food -> Washout period for over 1 week -> Taking a test food 1 -> Washout period for over 1 week -> Taking a test food 2
Interventions/Control_2
Taking a test food 1 -> Washout period for over 1 week -> Taking a test food 2 -> Washout period for over 1 week -> Taking a placebo food
Interventions/Control_3
Taking a test food 2 -> Washout period for over 1 week -> Taking a placebo food -> Washout period for over 1 week -> Taking a test food 1
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Healthy males and females from 20 to 64 years old.
2) Subjects who are sensitive to cold.
3) Subjects whose written informed consent has been obtained.
Key exclusion criteria
1) Subjects who were diagnosed as oversensitiveness to cold by medical doctor.
2) Subjects who are undergoing some kind of drug treatment.
3) Subjects who constantly use oral medicines, functional foods or supplements which improve fatigue, blood flow, coldness or stress.
4) Females who are pregnant or lactating, and who could become pregnant during test period.
5) Subjects who have current or previous medical history of serious disease.
6) Subjects who consume excessive alcohol.
7) Smoker.
8) Subjects who have extremely irregular habits of dining, and who have irregular lifestyle rhythms.
9) Subjects who have allergy to drug or food.
10) Subjects who have cold allergy.
11) Subjects who are participating the other clinical tests. Subjects who participated within 4-weeks prior to the current study or who plan to participate the other clinical tests.
12) Subjects who have been determined ineligible by principal investigator or sub-investigator.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Shukuko |
| Middle name | |
| Last name | Ebihara |
Organization
Chiyoda Paramedical Care Clinic
Division name
Director
Zip code
101-0047
Address
2F Sanwauchikanda Building , 3-3-5 Uchikanda Chiyoda-ku, Tokyo, Japan
TEL
03-5297-5548
cpcc-contact@cpcc.co.jp
Public contact
Name of contact person
| 1st name | Mitsuhiro |
| Middle name | |
| Last name | Fujimoto |
Organization
CPCC Company Limited
Division name
Planning & Sales Department
Zip code
101-0047
Address
4F Sanwauchikanda Building , 3-3-5 Uchikanda Chiyoda-ku, Tokyo, 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
KOBAYASHI 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
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Sanwauchikanda 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
| 2019 | Year | 10 | Month | 20 | 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
| 2019 | Year | 09 | Month | 24 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 20 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 21 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 03 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 10 | Month | 09 | Day |
Last modified on
| 2020 | Year | 10 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043583
| Research Plan | |
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| Registered date | File name |
| Research case data | |
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