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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000042786
Receipt No. 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

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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
Email 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
Email cpcc-contact@cpcc.co.jp

Sponsor
Institute Meiji Co., Ltd.
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047350

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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