UMIN-CTR Clinical Trial

Public title

A clinical study to evaluate the safety of plant-extracts containing foods. (SME-2021-03-FOSHUS)

Acronym

A clinical study to evaluate the safety of plant-extracts containing foods.

Scientific Title

A clinical study to evaluate the safety of plant-extracts containing foods. (SME-2021-03-FOSHUS)

Scientific Title:Acronym

A clinical study to evaluate the safety of plant-extracts containing foods.

Region

Japan

Condition

Not applicable

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate the safety of plant-extracts foods.

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Incidence of adverse reactions

Key secondary outcomes

Incidence of adverse events
Laboratory data, Vital sign

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Dose comparison

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

3

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Daily intake of test food 1 for four weeks

Interventions/Control_2

Daily intake of test food 2 for four weeks

Interventions/Control_3

Daily intake of control food for four weeks

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) Those who are -> 20 years old at the time of IC acquisition and <65 years old at the end of food intake
(2) Those who have submitted written informed consent after fully understanding the purpose and content of this study

Key exclusion criteria

(1) Those with systolic blood pressure less than 90 mmHg at the start of ingestion
(2) Women who are/might be pregnant or lactating during the study
(3) Those who have taken >=200 mL whole blood or blood donation within 4 weeks before the start of the intake
(4) Men who have taken =>400 mL whole blood within 12 weeks before the start of intake
(5) Women who have taken =>400 mL whole blood within 16 weeks before the start of intake
(6) Men who have taken =>1,200 mL whole blood total (including the sampling of this study) within 12 months before the start of intake
(7) Women who have taken =>800 mL whole blood total (including the sampling of this study) within 12 months before the start of intake
(8) Those who are participating in other study or planning to participate or participated within the past 4 weeks
(9) Those 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 test foods
(10) Those who are receiving any treatment at the time of screening
(11) Those who regularly use pharmaceuticals (including quasi-drugs), foods for specified health use, foods with functional claims or health foods
(12) Those who smoke an average of 21 or more cigarettes in a day
(13) Those who drink an average of more than 60 g of pure alcohol in a day
(14) Those who have an extremely irregular eating habit
(15) Shift workers or late night workers
(16) Others who are judged inappropriate for participant by the investigator

Target sample size

72

Name of lead principal investigator

1st name	Takao
Middle name
Last name	Tanaka

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

Takao_Tanaka@suntory.co.jp

Name of contact person

1st name	Kazuto
Middle name
Last name	Shiga

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

Homepage URL

Email

Kazuto_Shiga@suntory.co.jp

Institute

SUNTORY MONOZUKURI EXPERT LIMITED

Institute

Department

Personal name

Organization

SUNTORY BEVARAGE & FOOD LIMITED

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Miura Clinic, Medical Corporation Kanonkai IRB

Address

Higashitenma building 9F, 1-7-17, Higashitenma, Kita-ku, Osaka

Tel

06-6135-5200

Email

mterashima@miura-cl.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

医療法人花音会みうらクリニック

Date of disclosure of the study information

2021

Year

09

Month

10

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

2021

Year

09

Month

09

Day

Date of IRB

2021

Year

09

Month

09

Day

Anticipated trial start date

2021

Year

09

Month

10

Day

Last follow-up date

2021

Year

11

Month

18

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2021

Year

09

Month

09

Day

Last modified on

2022

Year

05

Month

31

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051870