UMIN-CTR Clinical Trial

Public title

Study of effects of food containing polyphenol on lipid exclusion.

Acronym

Study of effects of food containing polyphenol on lipid exclusion.

Scientific Title

Study of effects of food containing polyphenol on lipid exclusion.

Scientific Title:Acronym

Study of effects of food containing polyphenol on lipid exclusion.

Region

Japan

Condition

No

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To examine effects of food containing polyphenol on lipid exclusion.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The amount of fecal lipid

Key secondary outcomes

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

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Food containing polyphenol, feeding three times a day for 10 days in term1.
Placebo food not containing polyphenol, feeding three times a day for 10 days in term2.

Interventions/Control_2

Placebo food not containing polyphenol, feeding three times a day for 10 days in term1.
Food containing polyphenol, feeding three times a day for 10 days in term2.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

65

years-old

>

Gender

Male and Female

Key inclusion criteria

(1)(Healthy) subjects who are the age of 20 to less than the age of 65 years old.
(2)Subjects who don't have dependency relationship with the site investigator.
(3)Subjects giving written informed consent.

Key exclusion criteria

(1)Subjects who have possible allergy symptoms onset.
(2)Subjects who have fecal evacuation less than 5 times per week.
(3)Subjects who have food intake less than twice per day.
(4)Subjects who have under treatment or with history of drug addiction or alcoholism.
(5)Subjects who have extremely irregular dietary habits.
(6)Subjects who have any history of serious disease (e.g. heart disease, respiratory disorder, digestive disturbance, endocrine disorder, metabolic disturbance, metabolic disturbance, food allergy).
(7)Subjects who have kidney disease, liver disease, infectious disease, viral infection.
(8)Subjects who constantly use pharmaceuticals for chronic malady.
(9)Subjects who have an operation history related to a digestive organ
(10)Subjects who donate over 200 mL of blood or blood component within the last one month prior to this study or over 400 mL blood or blood component within the last three months prior to this study.
(11)Subjects who are graveyard shift worker or irregular shift worker.
(12)Subjects who have irregular life style in the test period.
(13)Subjects who constantly use of pharmaceuticals, dietary supplements or functional foods affecting lipid metabolism or intestinal function.
(14)Subjects who have excessive alcohol-drinking behavior (over 20 g alcohol/day).
(15)Subjects who are possible pregnancy or pregnancy or lactating.
(16)Subjects who are unable to stop drinking the day before the study check day.
(17)Subjects who participate in another clinical study or possible participation in another clinical study.
(18)Subjects who are judged anemic during the pre-check.
(19)Subjects who are judged ineligible during the pre-checker by the site investigators.
(20)Subjects who are judged ineligible during the test period by the site investigators for any other reason.
(21)Subjects who are working for a functional food company.

Target sample size

25

Name of lead principal investigator

1st name
Middle name
Last name	Ikuo Fukuhara

Organization

Fukuhara Clinic

Division name

Director

Zip code

Address

3-1-15 ,Shimamatuhigashimati, Eniwa-shi,Hokkaido,Japan

TEL

0123-36-8029

Email

i-feniwa@gray.plala.or.jp

Name of contact person

1st name
Middle name
Last name	Shimpei Tomita

Organization

New Drug Research Center, Inc.

Division name

Clinical Research Dept.

Zip code

Address

452-1,Toiso,Eniwa-shi,Hokkaido,Japan

TEL

0123-34-0412

Homepage URL

Email

s-tomita@ndrcenter.co.jp

Institute

New Drug Research Center, Inc.

Institute

Department

Personal name

Organization

Kirin Co., Ltd.

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

Date of disclosure of the study information

2015

Year

12

Month

31

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

2014

Year

09

Month

29

Day

Date of IRB

Anticipated trial start date

2014

Year

10

Month

29

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Protocol No. 14113

Registered date

2015

Year

07

Month

31

Day

Last modified on

2016

Year

01

Month

12

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021413