UMIN-CTR Clinical Trial

Public title

Pharmacokinetics study of drinks containing functional ingredient.

Acronym

Pharmacokinetics study of drinks containing functional ingredient.

Scientific Title

Pharmacokinetics study of drinks containing functional ingredient.

Scientific Title:Acronym

Pharmacokinetics study of drinks containing functional ingredient.

Region

Japan

Condition

Healthy male adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate the pharmacokinetics of food ingredient for male subjects ranging in age from 20 to 65 years old.

Basic objectives2

Pharmacokinetics

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

AUC

Key secondary outcomes

Study type

Interventional

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Cluster

Blinding

Open -no one is blinded

Control

Dose comparison

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Single ingestion of test food.

Interventions/Control_2

Twice daily ingestion of test foods.

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

Key inclusion criteria

(1) Male subjects ranging in age from 20 to 65 at informed consent.
(2) Subjects ranging in BMI from 25 to less than 30 kg/m2.
(3) Subjects who can visit the designated facility on admission days.
(4) Subjects who can make self-judgment and voluntarily gave written informed consent.

Key exclusion criteria

(1)Subjects who are with treatment.
(2)Subjects who are with history of gastrointestinal surgery.
(3) Subjects with a maximal blood pressure of less than 90 mmHg.
(4) Subjects who donated their blood components and/or whole blood (0.2 L) within the past 4 weeks.
(5) Subjects who donated their whole blood (0.4 L) within the past 12 weeks.
(6) Subjects being collected in total of their blood (1.2 L) within the past 12 months and in this research.
(7) Subjects being under other clinical tests, or partook in those within the past four weeks, or will join those after the consent.
(8) Subjects who meet any of the following:
(a) suffering from heart, liver, or kidney disease (including complications of other diseases)
(b) having a history of cardiovascular disease
(c) diabetes
(d) allergic to the test food and required one.
(9) Subjects having drug or food allergy.
(10) Subjects having severe anemia
(11) Subjects who have experience illness or deterioration of physical condition due to blood sampling in the past.
(12) Subjects who have difficulty in having blood drawn from a peripheral blood vein.

(13) Subjects with excessive alcohol intake.
(14) Subjects having a habit of smoking.
(15) Subjects having extremely irregular eating habits.
(16) Shift workers or late night workers.
(17) Patients who have used medicines within one week prior to consumption of the test food
(18) Subjects who have periodically used health-specific / functional / health foods including supplements, which might affect the test.
(19) Subjects who are not negative for HBs antigen, HCV antibody test.
(20) Others who were judged as inappropriate for participation by the principal/sub investigator.

Target sample size

24

Name of lead principal investigator

1st name	Hisako
Middle name
Last name	Minami

Organization

Suntory beverage & Food limited.

Division name

Development & Designed Department

Zip code

2110067

Address

13-2 Imaikami-cho, Nakahara-ku, Kawasaki, Kanagawa, JAPAN

TEL

050-3182-6161

Email

Hisako_Nakamura@suntory.co.jp

Name of contact person

1st name	Mariko
Middle name
Last name	Sato

Organization

Suntory beverage & Food limited.

Division name

Development & Designed Department

Zip code

2110067

Address

13-2 Imaikami-cho, Nakahara-ku, Kawasaki, Kanagawa, JAPAN

TEL

05031820954

Homepage URL

Email

Mariko_Sato@suntory.co.jp

Institute

CPCC Company Limited.

Institute

Department

Personal name

Organization

Suntory beverage & Food limited.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Seishukai Clinic Institutional Review Board

Address

3-18-5 Matsugaya, Taito-ku, Tokyo

Tel

03-5827-0930

Email

k-sudo@seishukai.or.jp

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

2023

Year

10

Month

23

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

2023

Year

10

Month

10

Day

Date of IRB

2023

Year

10

Month

20

Day

Anticipated trial start date

2023

Year

10

Month

25

Day

Last follow-up date

2023

Year

12

Month

29

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2023

Year

10

Month

23

Day

Last modified on

2024

Year

05

Month

09

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060001