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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000010717
Receipt No. 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

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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
Email 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
Email ochiai.ryuuji@kao.com

Sponsor
Institute Kao Corporation
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012526

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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