UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026285
Receipt number R000030145
Scientific Title A Study to Evaluate the Safety of Long Term Consumption of Food Containing Plant Extract.
Date of disclosure of the study information 2017/02/26
Last modified on 2021/02/17 15:52:06

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Basic information

Public title

A Study to Evaluate the Safety of Long Term Consumption of Food Containing Plant Extract.

Acronym

A Study to Evaluate the Safety of Long Term Consumption of Food Containing Plant Extract.

Scientific Title

A Study to Evaluate the Safety of Long Term Consumption of Food Containing Plant Extract.

Scientific Title:Acronym

A Study to Evaluate the Safety of Long Term Consumption of Food Containing Plant Extract.

Region

Japan


Condition

Condition

Healthy Adult (including borderline diabetes)

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the safety of long term consumption of food containing plant extract for 12 weeks in healthy adults.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Inquiry, physical examination, medical examination by hematology,blood biochemistry, urinalysis.

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

Test food containing plant extract, 12 weeks 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

64 years-old >=

Gender

Male and Female

Key inclusion criteria

(1) 20<=Age=<64 of healty men and women
(2) Subjects who are judged as normoglycemic or borderline diabetes by the investigator
(3) Subjects who can make self-judgments and voluntarily give written informed consents

Key exclusion criteria

(1) Subjects with a medical history of diabetes, liver disease, kidney disease, gastrointestinal disease, peripheral vascular disease, or severe diseases
(2) Subjects with a disorder in heart and lung function
(3) Subjects with abnormal parameters in liver or kidney function
(4) Subjects who had a gastrointestinal surgery
(5) Subjects with a disease currently under treatment
(6) Subjects with drug or food allergies
(7) Subjects with anemic
(8) Subjects who play high intensity sports or are on a diet
(9) Subjects who are taking supplemental foods, quasi drugs or drug products (including OTC or prescribed medication) containing ingredient of test food
(10) Subjects who drink excessive alcohol, or who cannot stop drinking alcohol at one day prior to the test day and the day of the test
(11) Subjects who have been pregnant or subjects who have a plan to become pregnant or breast feed during the study period
(12) Subjects who is participating in other studies or planning to participate during the study period
(13) Subjects who are deemed unsuitable by the investigator for other reasons

Target sample size

15


Research contact person

Name of lead principal investigator

1st name Naoki
Middle name
Last name Miura

Organization

Miura Clinic, Medical Corporation Kanonkai

Division name

Internal Medicine

Zip code

530-0044

Address

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

TEL

06-6135-5200

Email

tterashima@miula.co.jp


Public contact

Name of contact person

1st name Makoto
Middle name
Last name Terashima

Organization

Oneness support Co., Ltd.

Division name

Clinical trial Division

Zip code

530-0044

Address

Higashitenma building 4F, 1-7-17, Higashitenma, Kita-ku, Osaka, Osaka

TEL

06-4801-8917

Homepage URL


Email

mterashima@oneness-sup.co.jp


Sponsor or person

Institute

Oneness support Co., Ltd.

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

The Ethics Committee of Miura Clinic, Medical Corporation Kanonkai

Address

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

Tel

06-6135-5200

Email

tterashima@miula.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

2017 Year 02 Month 26 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

2017 Year 02 Month 17 Day

Date of IRB


Anticipated trial start date

2017 Year 02 Month 28 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 02 Month 24 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=R000030145


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name