UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of cacao polyphenol on endothelial function: systematic review of RCT
Title of the study (Brief title)	Effect of cacao polyphenol on endothelial function
Region	Japan

Condition
Condition	Endothelial function
Classification by specialty	Cardiology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess the effect of oral cocoa polyphenols intake on vascular endothelial function.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	FMD (Flow-Mediated Dilatation)
Key secondary outcomes

Base
Study type	Others,meta-analysis etc

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	P: Subjects who measured FMD. I: Oral intake of cacao polyphenols C:Placebo or no intake of cacao polyphenols O: FMD S: RCT
Key exclusion criteria	1) non oral intake 2) nonclinical study 3) non-RCT 4) not conducted FMD
Target sample size	100

Research contact person
Name of lead principal investigator	Kohsuke Hayamizu
Organization	Yokohama University of Pharmacy
Division name	Food Chemistry Laboratory
Address	601 Matano-cho, Totsuka-ku, Yokohama, Kanagawa, JAPAN
TEL	045-859-1300
Email	k.hayamizu@hamayaku.ac.jp

Public contact
Name of contact person	Kohsuke Hayamizu
Organization	Yokohama University of Pharmacy
Division name	Food Chemistry Laboratory
Address	601 Matano-cho, Totsuka-ku, Yokohama, Kanagawa, JAPAN
TEL	045-859-1300
Homepage URL
Email	k.hayamizu@hamayaku.ac.jp

Sponsor
Institute	Yokohama University of Pharmacy
Institute
Department

Funding Source
Organization	Yokohama University of Pharmacy
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2018 Year 04 Month 01 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2017 Year 08 Month 03 Day
Anticipated trial start date	2017 Year 11 Month 28 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information	On going data serach

Management information
Registered date	2017 Year 11 Month 28 Day
Last modified on	2018 Year 05 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000034436