UMIN-CTR Clinical Trial

Public title

A study of excessive intake of the food containing plant-derived ingredient.
(SME-2019-02-FOSHUS)

Acronym

A study of excessive intake of the food containing plant-derived ingredient.

Scientific Title

A study of excessive intake of the food containing plant-derived ingredient.
(SME-2019-02-FOSHUS)

Scientific Title:Acronym

A study of excessive intake of the food containing plant-derived ingredient.

Region

Japan

Condition

Not applicable

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate the safety of food

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Expression rate of side effects

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

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

Prevention

Type of intervention

Food

Interventions/Control_1

Four weeks repeated intake of the test foods

Interventions/Control_2

Four weeks repeated intake of the control 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 and Female

Key inclusion criteria

(1)Healthy male and female whose age are 20 <= years old <65.
(2)Subjects who are able to visit
medical institution on the stipulated date.
(3)Subjects who are able to submit the written informed consents.

Key exclusion criteria

(1) Subjects who are with treatment.
(2) Subjects whose systolic pressure <90 mmHg.
(3) Females in pregnancy,lactation and scheduled pregnancy period.
(4) Subjects who donated over 200ml blood components or whole blood within 4 weeks.
(5) Male Subjects who donated over 400ml whole blood within 12 weeks.
(6) Female who donated over 400ml whole blood within 16 weeks.
(7) Male subjects whose blood was collected more than 1200 mL within the last twelve months when the amount of blood sampling in the current study is added.
(8) Female subjects whose blood was collected more than 800 mL within the last twelve months when the amount of blood sampling in the current study is added.
(9) Subjects who are participating in other clinical studies, or who finished clinical study within 4 weeks.
(10) Subjects who are;
(a)With present heart disorder,liver disorder,or kidney disorder.
(b)With history of cardiac disorder.
(c)With diabetes mellitus.
(d)With allergy to drugs or foods.
(e)With glaucoma.
(f)With hyponatremia.
(11) Subjects who constantly use supplements and/or functional foods (including Food for Specified Health Uses) affecting the test results.
(12) Subjects who drink alcohol or smoke a lot.
(13) Subjects who have an extremely irregular diet habit or alternative work schedule or work on midnight shift.
(14) Subjects who themselves or family living together work at a company that plans, researches, develops, manufactures or sells supplements and/or functional foods (including Food for Specified Health Uses).
(15) Subjects who are deemed to be unsuitable by the investigator.

Target sample size

48

Name of lead principal investigator

1st name	Hidenori
Middle name
Last name	Obata

Organization

Suntory MONOZUKURI Expert Limited

Division name

R&D Support Department, HE Center

Zip code

135-8631

Address

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

TEL

03-5579-1277

Email

Hidenori_Obata@suntory.co.jp

Name of contact person

1st name	Keisuke
Middle name
Last name	Yasumoto

Organization

Suntory MONOZUKURI Expert Limited

Division name

R&D Support Department, HE Center

Zip code

619-0284

Address

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

TEL

0774-66-1110

Homepage URL

Email

Keisuke_Yasumoto@suntory.co.jp

Institute

Suntory MONOZUKURI Expert 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

Institutional Review Board of Takara Clinic

Address

2-3-2 Higashigotanda, Shinagawa-ku, Tokyo, Japan

Tel

03-5793-3623

Email

info@takara-clinic.com

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

2019

Year

07

Month

29

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

2019

Year

07

Month

29

Day

Date of IRB

2019

Year

07

Month

29

Day

Anticipated trial start date

2019

Year

07

Month

30

Day

Last follow-up date

2019

Year

12

Month

15

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2019

Year

07

Month

29

Day

Last modified on

2020

Year

11

Month

05

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042773