UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013283
Receipt number R000015179
Scientific Title Effects of chlorogenic acids in hydroxyhydroquinone-reduced coffee on vascular endothelial function in hypertension patients.
Date of disclosure of the study information 2014/04/01
Last modified on 2019/06/06 17:42:24

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Basic information

Public title

Effects of chlorogenic acids in hydroxyhydroquinone-reduced coffee on vascular endothelial function in hypertension patients.

Acronym

Effects of chlorogenic acids in hydroxyhydroquinone-reduced coffee on vascular endothelial function in hypertension patients.

Scientific Title

Effects of chlorogenic acids in hydroxyhydroquinone-reduced coffee on vascular endothelial function in hypertension patients.

Scientific Title:Acronym

Effects of chlorogenic acids in hydroxyhydroquinone-reduced coffee on vascular endothelial function in hypertension patients.

Region

Japan


Condition

Condition

Hypertension

Classification by specialty

Medicine in general Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study was to determine the effects of chlorogenic acids in hydroxyhydroquinone-reduced coffee on endothelial function in subjects with mild hypertension.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

endothelial function (FMD)

Key secondary outcomes



Base

Study type


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Chlorogenic acids in hydroxyhydroquinone-reduced coffee

Interventions/Control_2

Chlorogenic acids in hydroxyhydroquinone-nonereduced coffee

Interventions/Control_3

placebo coffee

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

30 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

We enrolled mild hypertension patients(systolic blood pressure (SBP): 130 to 159&#8201;mm&#8201;Hg, diastolic blood pressure (DBP): 99&#8201;mm&#8201;Hg or less) without diabetes.

Key exclusion criteria

We enrolled the subjects who were not taking statin or renin angiotensin system inhibitors.
allergy to coffee
pregnancy

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Higashi Yukihito

Organization

Hiroshima University Hospital

Division name

Division of Regeneration and Medicine

Zip code


Address

1-2-3 Kasumi, Minami-ku, Hiroshima

TEL

+81-82-257-5831

Email

yhigashi@hiroshima-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Higashi Yukihito

Organization

Hiroshima University Hospital

Division name

Division of Regeneration and Medicine

Zip code


Address

1-2-3 Kasumi, Minami-ku, Hiroshima

TEL

+81-82-257-5831

Homepage URL


Email

yhigashi@hiroshima-u.ac.jp


Sponsor or person

Institute

Division of Regeneration and Medicine, Hiroshima University Hospital

Institute

Department

Personal name



Funding Source

Organization

contributions

Organization

Division

Category of Funding Organization

Self funding

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

2014 Year 04 Month 01 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


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

2014 Year 04 Month 01 Day

Date of IRB

2014 Year 02 Month 26 Day

Anticipated trial start date

2014 Year 04 Month 01 Day

Last follow-up date

2016 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 02 Month 26 Day

Last modified on

2019 Year 06 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015179


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name