UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034469
Receipt number R000039290
Scientific Title A Clinical Study for Evaluating the Safety of Excessive Consumption of Food Containing Plant Extract -Open Study-
Date of disclosure of the study information 2018/10/12
Last modified on 2021/02/17 16:16:38

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Basic information

Public title

A Clinical Study for Evaluating the Safety of Excessive Consumption of Food Containing Plant Extract
-Open Study-

Acronym

A Clinical Study for Evaluating the Safety of Excessive Consumption of Food Containing Plant Extract

Scientific Title

A Clinical Study for Evaluating the Safety of Excessive Consumption of Food Containing Plant Extract
-Open Study-

Scientific Title:Acronym

A Clinical Study for Evaluating the Safety of Excessive Consumption of Food Containing Plant Extract

Region

Japan


Condition

Condition

No

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the safety of excessive consumption of food containing plant extract

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Doctor's questions, Vital signs, Hematological test, Blood biochemical test, Urinalysis, Adverse event

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Foods containing plant extract, 4 weeks excessive consumption

Interventions/Control_2


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

65 years-old >

Gender

Male and Female

Key inclusion criteria

(1) Healthy males and females aged 20 to 64 years-old whose BMI are under 30.
(2) Subjects who can make self-judgment and are voluntarily giving written informed consent.

Key exclusion criteria

(1) Subjects who are under treatment with medications.
(2) Subjects who contract or are undertreatment for serious diseases (e.g., kidney disease, liver disease, digestive disease, heart disease, respiratory disease, endocrine disease, and/or metabolic disease).
(3) Subjects who can't stop using supplements and/or functional foods (including Food for Specified Health Uses and/or Foods with Function Claims) during test periods.
(4) Subjects who can't stop drinking from 2 days before each measurement.
(5) Subjects who have declared allergic reaction to ingredients of test foods.
(6) Subjects who have donated over 400mL of blood and/or bood components within the last three months prior to study initiation.
(7) Subjects who are planning to become pregnant after informed consent for the current study, pregnant or lactating.
(8) Subjects who are under treatment for or have a history of drug addiction and/or alcoholism.
(9) Subjects who are planning to participate in other clinical studies during test periods and/or had participated in other clinical studies within the last one month prior to the current study.
(10) Subjects who are judged as unsuitable for the current study by the investigator or subinvestigators for other reasons.

Target sample size

15


Research contact person

Name of lead principal investigator

1st name Yoshitaka
Middle name
Last name Iwama

Organization

Nihonbashi Cardiology Clinic

Division name

Director

Zip code

103-0001

Address

Kyodo Bldg. #201, 13 - 4 Nihonbashi Kodenmacho, Chuo-ku, Tokyo

TEL

03-5641-4133

Email

yiwama@well-sleep.jp


Public contact

Name of contact person

1st name Yoshika
Middle name
Last name Komori

Organization

KSO Corporation

Division name

Sales department

Zip code

105-0023

Address

1-9-7 Shibaura, Minato-ku, Tokyo

TEL

03-3452-7733

Homepage URL


Email

yoshi@kso.co.jp


Sponsor or person

Institute

KSO Corporation

Institute

Department

Personal name



Funding Source

Organization

TOYO SHINYAKU Co., Ltd.

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

Ethical Committee of Kobuna Orthopedics Clinic

Address

311-2 Gokan-machi, Maebashi-shi, Gumma

Tel

027-212-5608

Email

sagawa@mc-connect.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



Other administrative information

Date of disclosure of the study information

2018 Year 10 Month 12 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

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



Progress

Recruitment status

Completed

Date of protocol fixation

2018 Year 10 Month 04 Day

Date of IRB

2018 Year 10 Month 11 Day

Anticipated trial start date

2018 Year 10 Month 13 Day

Last follow-up date

2018 Year 12 Month 11 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 10 Month 12 Day

Last modified on

2021 Year 02 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039290


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name