UMIN-CTR Clinical Trial

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

Healthy adult

Classification by specialty

Endocrinology and Metabolism

Adult

Classification by malignancy

Others

Genomic information

NO

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

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.

Study type

Interventional

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

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

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

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

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

Institute

Kao Coporation

Institute

Department

Personal name

Organization

Kao Coporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

花王株式会社生物科学研究所（栃木県）

Date of disclosure of the study information

2016

Year

12

Month

21

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2016

Year

12

Month

21

Day

Last modified on

2017

Year

06

Month

21

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029185