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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025355
Receipt No. R000029185
Scientific Title Influence of oxidative components on a vascular function improvement effect of polyphenol.
Date of disclosure of the study information 2016/12/21
Last modified on 2017/06/21

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Basic information
Public title Influence of oxidative components on a vascular function improvement effect of polyphenol.
Acronym Influence of oxidative components on a vascular function improvement effect of polyphenol.
Scientific Title Influence of oxidative components on a vascular function improvement effect of polyphenol.
Scientific Title:Acronym Influence of oxidative components on a vascular function improvement effect of polyphenol.
Region
Japan

Condition
Condition Healthy adult
Classification by specialty
Endocrinology and Metabolism Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To confirm the effects of oxidative components on oxidative stress markers and vascular function.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Blood samples were collected before ingestion and at 0.5,1 and 2 hours after ingestion. FMD was measured before and 1, 2 and 4 hours after ingestion. Urine samples were collected before ingestion and accumulation urine samples were pooled during the postprandial periods for 2 and 4 hrs.
Primary outcomes are oxidative stress markers and vascular endothelial function.
Key secondary outcomes Key secondary outcomes are blood glucose.

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved 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 A drink: The polyphenol drink containing an oxidization component.
B drink: The polyphenol drink which reduced the oxidization component by X treatment.
C drink: The polyphenol drink which reduced the oxidization component by Y treatment.
The subjects ingested a single intake of A drink, and ingested a single intake of B drink after 7 days, and also ingested a single intake of C drink after 7 days.
Interventions/Control_2 The subjects ingested a single intake of B drink, and ingested a single intake of C drink after 7 days, and also ingested a single intake of A drink after 7 days.
Interventions/Control_3 The subjects ingested a single intake of C drink, and ingested a single intake of A drink after 7 days, and also ingested a single intake of B drink after 7 days.
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
25 years-old <=
Age-upper limit
50 years-old >=
Gender Male
Key inclusion criteria 1) Subjects whose fasting blood glucose levels are ranged to less than 126mg/dL
2) Subjects whose HbA1c1 levels are ranged to less than 6.2%
3) Subjects whose BMI are from 18.5 Kg/m2 to less than 35 Kg/m2
4) Subjects who can make self-judgment and are voluntarily giving written informed consent
Key exclusion criteria 1) Subjects who take continuous medical treatment
2) Subjects who are contracting heart disease, liver disease, kidney disease, digestive disease and allergy disease
3) Subjects with smoking habit
4) Subjects who are not eligible due to physician's judgment
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Noriyasu Ota
Organization Kao Coporation
Division name R&B-Core Technology-Biological Science Research
Zip code
Address 2606,Akabane,Ichikai-Machi,Haga-Gun,Tochigi,321-3497,Japan
TEL 0285-68-7828
Email ota.noriyasu@kao.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroko Jokura
Organization Kao Coporation
Division name R&B-Core Technology-Biological Science Research
Zip code
Address 2606,Akabane,Ichikai-Machi,Haga-Gun,Tochigi,321-3497,Japan
TEL 0285-68-7164
Homepage URL
Email joukura.hiroko@kao.co.jp

Sponsor
Institute Kao Coporation
Institute
Department

Funding Source
Organization Kao Coporation
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 花王株式会社生物科学研究所(栃木県)

Other administrative information
Date of disclosure of the study information
2016 Year 12 Month 21 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
2016 Year 10 Month 25 Day
Date of IRB
Anticipated trial start date
2016 Year 11 Month 07 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 12 Month 21 Day
Last modified on
2017 Year 06 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029185

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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