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 mm Hg, diastolic blood pressure (DBP): 99 mm 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
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
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
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
