UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023556
Receipt number R000027129
Scientific Title Blood concentration of plant extract by the intake of beverage containing it (Ex.no.H28-0701)
Date of disclosure of the study information 2017/03/31
Last modified on 2020/03/31 15:39:35

* 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

Blood concentration of plant extract by the intake of beverage containing it
(Ex.no.H28-0701)

Acronym

Blood concentration of plant extract by the intake of beverage containing it

Scientific Title

Blood concentration of plant extract by the intake of beverage containing it
(Ex.no.H28-0701)

Scientific Title:Acronym

Blood concentration of plant extract by the intake of beverage containing it

Region

Japan


Condition

Condition

Healthy Adult

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate blood concentration of plant extract by the intake of beverage.

Basic objectives2

Pharmacokinetics

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Blood concentration after the intake of beverage

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

test food containing plant extract

Interventions/Control_2

control food containing plant extract

Interventions/Control_3


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

20 years-old <=

Age-upper limit

30 years-old >

Gender

Male

Key inclusion criteria

(1) (Healthy) subjects aged 20 to 29 years old.
(2) Subjects giving written informed consent.

Key exclusion criteria

(1) Subjects with serious medical history of hepatic, renal, cardiovascular, respiratory and intestinal disease.
(2) Subjects taking any kind of medicine or supplement which affect the result of the trial for habitual use.
(3) Subjects who might be liable to allergy related to the study.
(4) Subjects who are judged as unsuitable for the study by the investigator for the other reasons.

Target sample size

10


Research contact person

Name of lead principal investigator

1st name Jyouji
Middle name
Last name Kurokawa

Organization

Iryouhoujinshadanshoureikan Shinsapporo Seiryou Hospital

Division name

General Clinical Department

Zip code

004-0004

Address

1-30, Atsubetsuhigashi4jo, Atsubetsu-ku, Sapporo city, Hokkaido

TEL

011-898-2151

Email

seiryo_kurokawa@yahoo.co.jp


Public contact

Name of contact person

1st name Soichi
Middle name
Last name Yoneda

Organization

QOL RD Co.,Ltd.

Division name

CRO Department Food Division

Zip code

103-0027

Address

2-14-1,Nihonbashi,Chuo-Ku,Tkyo,Japan

TEL

03-6386-8809

Homepage URL


Email

s-yoneda@qol-rd.co.jp


Sponsor or person

Institute

QOL RD Co.,Ltd.

Institute

Department

Personal name



Funding Source

Organization

Kao Corporation

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

Kanazawa Bunko Hospital IRB

Address

2-6-22, Kamariya Higashi, Kanazawa-ku, Yokohama

Tel

045-785-3311

Email

nagashima@kanabun-hp.jp


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

医療法人社団翔嶺館 新札幌聖陵ホスピタル(北海道)


Other administrative information

Date of disclosure of the study information

2017 Year 03 Month 31 Day


Related information

URL releasing protocol

Unpublished due to the protocol including the intellectual property rights

Publication of results

Unpublished


Result

URL related to results and publications

works in progress

Number of participants that the trial has enrolled

10

Results

Blood levels were within the expected range.

Results date posted

2020 Year 03 Month 31 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Healthy men

Participant flow

10 participants completed and 10 subjects were incorporated into the analyses

Adverse events

No adverse effect related to the test diets reported

Outcome measures

Blood concentration of ingredients

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2016 Year 07 Month 28 Day

Date of IRB

2016 Year 07 Month 28 Day

Anticipated trial start date

2016 Year 08 Month 10 Day

Last follow-up date

2017 Year 03 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 08 Month 09 Day

Last modified on

2020 Year 03 Month 31 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027129


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name