UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000032524
Receipt number R000037094
Scientific Title Effect of coffee chlorogenic acid in grade I hypertension and high-normal blood pressure on blood pressure: a meta-analysis using individual participant data
Date of disclosure of the study information 2018/05/20
Last modified on 2018/11/08 06:57:15

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Basic information

Public title

Effect of coffee chlorogenic acid in grade I hypertension and high-normal blood pressure on blood pressure: a meta-analysis using individual participant data

Acronym

A individual participant data meta-analysis of coffee chlorogenic acid.

Scientific Title

Effect of coffee chlorogenic acid in grade I hypertension and high-normal blood pressure on blood pressure: a meta-analysis using individual participant data

Scientific Title:Acronym

A individual participant data meta-analysis of coffee chlorogenic acid.

Region

Japan


Condition

Condition

in grade I hypertension and high-normal blood pressure

Classification by specialty

Cardiology Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This individual participant data (IPD) meta-analysis was to assess the overall effect of coffee chlorogenic acid supplementation on grade 1 hypertension and high-normal blood pressure.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

blood pressure (systolic blood pressure and diastolic blood pressure)

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Randomized controlled trials.

Participant: Grade I hypertension and/or high-normal blood pressure without treatments.
Intervention: Ingestion of coffee chlorogenic acid for 12 or more weeks.
Comparison: Placebo.
Outcome: Blood pressure.

Key exclusion criteria

Studies, which do not meet Key inclusion criteria were exclude

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kazuya Kozuma

Organization

Kao Corporation

Division name

Health Care Food Research lab

Zip code


Address

2-1-3, Bunka, Sumida-ku, Tokyo

TEL

03-563-7476

Email

kouzuma.kazuya@kao.com


Public contact

Name of contact person

1st name
Middle name
Last name Kazuya Kozuma

Organization

Kao Corporation

Division name

Health Care Food Research Labs.

Zip code


Address

2-1-3, Bunka, Sumida-ku, Tokyo

TEL

03-563-7476

Homepage URL


Email

kouzuma.kazuya@kao.com


Sponsor or person

Institute

Kao Corporation

Institute

Department

Personal name



Funding Source

Organization

Kao Corporation

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


Address


Tel


Email



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 05 Month 20 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results

Kozuma et al.
Effect of coffee chlorogenic acid in grade I hypertension and high-normal blood pressure Japanese adults on blood pressure: a meta-analysis using individual participant data from randomized controlled trials.
Jpn Pharmacol Ther. 2018; 46: 1157-1166

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

Main results already published

Date of protocol fixation

2018 Year 04 Month 25 Day

Date of IRB


Anticipated trial start date

2018 Year 05 Month 09 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Data sources
Medline (PubMed), JDream3 and University hospital Medical Information Network Clinical Trials Registry (UMIN-CTR)


Management information

Registered date

2018 Year 05 Month 09 Day

Last modified on

2018 Year 11 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037094


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name