UMIN-CTR Clinical Trial

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