UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Influence of oxidative components on a vascular function improvement effect of polyphenol.
Title of the study (Brief title)	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	Noriyasu Ota
Organization	Kao Coporation
Division name	R&B-Core Technology-Biological Science Research
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	Hiroko Jokura
Organization	Kao Coporation
Division name	R&B-Core Technology-Biological Science Research
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 10 Month 25 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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