UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020582
Receipt number R000023762
Scientific Title Blood concentration of functional coffee by the intake of beverage containing it.
Date of disclosure of the study information 2016/01/15
Last modified on 2019/08/22 15:48:18

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Basic information

Public title

Blood concentration of functional coffee by the intake of beverage containing it.

Acronym

Blood concentration of functional coffee by the intake of beverage containing it.

Scientific Title

Blood concentration of functional coffee by the intake of beverage containing it.

Scientific Title:Acronym

Blood concentration of functional coffee 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 coffee ingradients after 0, 0.5, 1, 1.5, 2, 5, 9hrs ingestion of functional coffee beverage.

Basic objectives2

PK,PD

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

To evaluate blood concentration of coffee ingradients after 0, 0.5, 1, 1.5, 2, 5, 9hrs ingestion of functional coffee 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

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Test coffee containing functional coffee ingredient->3day washout->Control coffee containing nonfunctional coffee ingredient

Interventions/Control_2

Control coffee containing nonfunctional coffee ingredient->3day washout->Test coffee containing functional coffee ingredient

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

60 years-old >

Gender

Male

Key inclusion criteria

(1) (Healthy) subjects aged 20 to 3559 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

20


Research contact person

Name of lead principal investigator

1st name Motooki
Middle name
Last name Keimatsu

Organization

Medical Corporation Hokubukai Utsukushigaoka hospital

Division name

Director

Zip code

004-0839

Address

61-1 Shinei Kiyota-ku Sapporo Hokkaido

TEL

011-882-0111

Email

utsukushigaoka@hokubu-g.co.jp


Public contact

Name of contact person

1st name Isao
Middle name
Last name Takehara

Organization

Clinical Support Corporation

Division name

Functional Foods Section

Zip code

060-0061

Address

4-1 South 1 West 8, Chuo-ku, Sapporo Hokkaido

TEL

011-223-3130

Homepage URL


Email

takehara@csc-smo.co.jp


Sponsor or person

Institute

Clinical Support Corporation

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

Hokubukai Utsukushigaoka Hospital

Address

61-1, Shinei, Kiyotaku-ku,Sapporo-city, Hokkaido

Tel

011-883-8881

Email

utsukushigaoka@hokubu-g.co.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

株式会社クリニカル・サポート・コーポレーション(北海道)


Other administrative information

Date of disclosure of the study information

2016 Year 01 Month 15 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

20

Results

Blood levels were within the expected range.

Results date posted

2019 Year 08 Month 07 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Healthy men

Participant flow

20 participants completed and 20 subjects were incorporated into the analyses

Adverse events

No adverse effect related to the test diets reported

Outcome measures

Blood concentration of functional coffee ingredients

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Main results already published

Date of protocol fixation

2016 Year 01 Month 14 Day

Date of IRB

2016 Year 02 Month 03 Day

Anticipated trial start date

2016 Year 02 Month 16 Day

Last follow-up date

2016 Year 05 Month 24 Day

Date of closure to data entry


Date trial data considered complete

2016 Year 05 Month 25 Day

Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 01 Month 15 Day

Last modified on

2019 Year 08 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023762


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name