UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022375
Receipt number R000025788
Scientific Title Exploratory study of food containing polyphenols.
Date of disclosure of the study information 2016/05/23
Last modified on 2017/04/13 09:12:02

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Exploratory study of food containing polyphenols.

Acronym

Exploratory study of food containing polyphenols.

Scientific Title

Exploratory study of food containing polyphenols.

Scientific Title:Acronym

Exploratory study of food containing polyphenols.

Region

Japan


Condition

Condition

Not applicable

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To explore effects, efficacy dose, and safety of food containing polyphenols.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Vascular function, 4, 8, and 12 weeks after start of the investigation, and 4 weeks after finish of the investigation

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Dose comparison

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

3

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Subjects will take the food containing polyphenols (low dose) for 12 weeks.

Interventions/Control_2

Subjects will take the food containing polyphenols (high dose) for 12 weeks.

Interventions/Control_3

Subjects will take the food containing no polyphenols (control) for 12 weeks.

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

30 years-old <=

Age-upper limit

70 years-old >

Gender

Male and Female

Key inclusion criteria

1)Subjects whose age are 30<= years old < 70.
2)Subjects who are able to visit the clinic on the assessment days.
3)Subjects who are able to understand the study and submit the written informed consents.

Key exclusion criteria

1)Females in pregnancy, lactation and scheduled pregnancy period.
2)Subjects who are attending other studies or attended other studies within past 4 weeks.
3)Subject who are receiving continuous medical treatment.
4)Subjects who are;
(a)With present heart disorder, liver disorder, or kidney disorder,
(b)With previous or present cardiac disorder,
(c)With diabetes mellitus, or
(d)With allergy to the study foods.
5)Subjects who are deemed to be unsuitable by the investigator.

Target sample size

120


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Junichi Nakamura

Organization

Suntory Business Expert Limited

Division name

HE Center

Zip code


Address

2-3-3 Daiba, Minato-ku, Tokyo 135-8631 Japan

TEL

03-5579-1277

Email

Junichi_Nakamura@suntory.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Akifumi Maeda

Organization

Suntory Business Expert Limited

Division name

HE Center

Zip code


Address

8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan

TEL

050-3182-0719

Homepage URL


Email

Akifumi_Maeda@suntory.co.jp


Sponsor or person

Institute

Suntory Business Expert Limited

Institute

Department

Personal name



Funding Source

Organization

Suntory Beverage & Food Limited

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



Other administrative information

Date of disclosure of the study information

2016 Year 05 Month 23 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 05 Month 19 Day

Date of IRB


Anticipated trial start date

2016 Year 05 Month 23 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 05 Month 20 Day

Last modified on

2017 Year 04 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025788


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name