UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042786 |
|---|---|
| Receipt number | R000047350 |
| Scientific Title | The study for the effects of Cacao extract on the peripheral blood flow |
| Date of disclosure of the study information | 2021/03/31 |
| Last modified on | 2021/04/01 10:23:36 |
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Basic information
Public title
The study for the effects of Cacao extract on the peripheral blood flow
Acronym
The study for the effects of Cacao extract on the peripheral blood flow
Scientific Title
The study for the effects of Cacao extract on the peripheral blood flow
Scientific Title:Acronym
The study for the effects of Cacao extract on the peripheral blood flow
Region
| Japan |
Condition
Condition
Poor circulation
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study exploratory about the effects of cacao extract for peripheral blood flow
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Blood flow
Body surface temperature
Key secondary outcomes
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
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Food containing Cacao extract
Interventions/Control_2
Food not containing Cacao extract
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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Persons who received a sufficient explanation of the purpose and contents of the exam, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate with a written document
2. Persons who are 20 years old or more and under 60 years old.
Key exclusion criteria
1)Persons with a severe or progressive condition or symptom
2) Persons with injury, inflammation or disease on his or her left hand
3) Persons with food allergy
4) Persons with cold allergy
5) Persons who cannot take foods containing cacao.
6) Persons who are in pregnancy, or who are willing to become pregnant
7) Persons who are breastfeeding
8) Smokers (including persons whose non-smoking period is less than 1 year)
9) Persons who participated in other clinical trial or monitor study within 1 month prior to screening
10) Persons who intake health foods, foods for specified health uses, foods with function claims that potentially influence the outcome of this study.
11) Persons who is ineligible for this study due to principal investigator's judgment
Target sample size
22
Research contact person
Name of lead principal investigator
| 1st name | TeruTarou |
| Middle name | |
| Last name | Shimamura |
Organization
Meiji Co., Ltd.
Division name
Group 2 Cacao Research and Development Food Development Laboratories R&D Division
Zip code
192-0919
Address
1-29-1 Nanakuni,Hachiouji,Tokyo
TEL
0426325829
terutarou.shimamura@meiji.com
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 Sanwa-uchikanda Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo
TEL
0352973112
Homepage URL
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
Meiji Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Meiji 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
Meiji Institutional Review Board
Address
1-29-1 Nanakuni, Hachiouji, Tokyo
Tel
042-632-5900
MEIJI.IRB@meiji.com
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
| 2021 | Year | 03 | 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
22
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
| 2020 | Year | 03 | Month | 26 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 26 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 03 | Day |
Last follow-up date
| 2020 | Year | 11 | Month | 07 | Day |
Date of closure to data entry
| 2020 | Year | 12 | Month | 24 | Day |
Date trial data considered complete
| 2020 | Year | 12 | Month | 24 | Day |
Date analysis concluded
| 2021 | Year | 03 | Month | 14 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 12 | Month | 18 | Day |
Last modified on
| 2021 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047350
