UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010717 |
|---|---|
| Receipt number | R000012526 |
| Scientific Title | Effects of hyperglycemia with chlorogenic acid on endothelial function. |
| Date of disclosure of the study information | 2013/05/14 |
| Last modified on | 2019/08/20 17:14:01 |
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Basic information
Public title
Effects of hyperglycemia with chlorogenic acid on endothelial function.
Acronym
Effects of chlorogenic acid on endothelial function.
Scientific Title
Effects of hyperglycemia with chlorogenic acid on endothelial function.
Scientific Title:Acronym
Effects of chlorogenic acid on endothelial function.
Region
| Japan |
Condition
Condition
healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We evaluated the acute effects of chlorogenic acid on endothelial function duaring glucose loading in healthy adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
RHI(Reactive Hypermia Index; endothelial function)
Key secondary outcomes
Blood pressure, blood parameters, urinary parameters
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants 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
225 ml of a 75-g glucose-equivalent test solution.
Interventions/Control_2
225 ml of a 75-g glucose-equivalent test solution with 600mg of chlorogenic acid.
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
Key inclusion criteria
Healthy Japanese men 20 to 60 years age.
Key exclusion criteria
Hypersensitivity or allergy to caffeine or coffee.
Medications treatment.
Inadequate with physician's decision.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Mitsuhiro |
| Middle name | |
| Last name | Katashima |
Organization
Kao Corporation
Division name
Health Care Food Research Labs.
Zip code
131-8501
Address
Bunka
TEL
0356307456
ochiai.ryuuji@kao.com
Public contact
Name of contact person
| 1st name | Ryuji |
| Middle name | |
| Last name | Ochiai |
Organization
Kao Corporation
Division name
Health Care Food Research Labs.
Zip code
131-8501
Address
Bunka
TEL
0356307456
Homepage URL
ochiai.ryuuji@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
The Human Ethics Committee of Kao Corporation
Address
2-1-3, Bunka Sumida-ku Tokyo 131-8501, Japan
Tel
03-5630-9596
kuzukawa.michiya@kao.co.jp
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
| 2013 | Year | 05 | Month | 14 | Day |
Related information
URL releasing protocol
Unpublished due to the protocol including the intellectual property rights
Publication of results
Published
Result
URL related to results and publications
http://www.sciencedirect.com/science/article/pii/S0271531713002686
Number of participants that the trial has enrolled
15
Results
A single ingestion of Chlorogenic acid improves peripheral endothelial function after glucose loading in healthy subjects.
Results date posted
| 2019 | Year | 08 | Month | 20 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Healthy men
Participant flow
15 participants completed and 14 subjects were incorporated into the analyses
Adverse events
No adverse effect related to the test diets reported
Outcome measures
RHI(Reactive Hypermia Index; endothelial function)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2010 | Year | 08 | Month | 03 | Day |
Date of IRB
| 2010 | Year | 08 | Month | 03 | Day |
Anticipated trial start date
| 2010 | Year | 09 | Month | 13 | Day |
Last follow-up date
| 2010 | Year | 12 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 05 | Month | 14 | Day |
Last modified on
| 2019 | Year | 08 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012526
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
