UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030585
Receipt number R000034925
Scientific Title Safety evaluation of an excessive consumption of a botanical extract-formulated food - Placebo control double blind parallel group comparison clinical trial -
Date of disclosure of the study information 2018/01/05
Last modified on 2018/05/08 14:49:27

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Safety evaluation of an excessive consumption of a botanical extract-formulated food
- Placebo control double blind parallel group comparison clinical trial -

Acronym

Safety evaluation of an excessive consumption of a botanical extract-formulated food

Scientific Title

Safety evaluation of an excessive consumption of a botanical extract-formulated food
- Placebo control double blind parallel group comparison clinical trial -

Scientific Title:Acronym

Safety evaluation of an excessive consumption of a botanical extract-formulated food

Region

Japan


Condition

Condition

healthy subjects

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the safety of excessive consumption of a botanical extract-formulated food for 4weeks.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

< Safety>
Side effect incidence,Adverse event incidence, clinical examination items, physiological examination items

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

study food
5 times of serving size per day for 4 weeks, safety evaluations are performed at 0, 2, 4 and 6 weeks.

Interventions/Control_2

Control food
5 times of serving size per day for 4 weeks, safety evaluations are performed at 0, 2, 4 and 6 weeks.

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 who females equal to or more than 20 years and less than 65 years of age
2.Subjects who can visit the medical institution at the scheduled visit date
3. Subjects who are able to understand the study and willing to provide written informed consent.

Key exclusion criteria

1. Subjects who systolic blood pressure is less than 90 mmHg.
2. Subjects who equal to or more than 30kg/m2of BMI.
3. Subjects who fall under diagnostic criteria of metabolic syndrome
4. Subjects who given surgery, or taken medication due to serious illness within a month
5. Subject who present heart, liver, kidney disorders.
6. Subjects who are taking drugs, foods for specified health use or functional foods which could affect this study. 7. Subjects who Females in pregnancy, lactation
and scheduled pregnancy period.
8. Subjects who with heavy use of alcohol, and heavy smoking.
9. Subject who have been felt ill by blood collection.
10. Subjects who donated 200 ml or more of blood within a month prior to the study
11.Subjects who with irregular eating habits.(Night shift worker)
12. Subjects who plan business trip or trip for 10 consecutive days or more.
13. Subjects who have allergy related to the study foods
14. Subjects who have chronic
diarrhea or chronic coprostasis
15. Subjects already participating in other clinical trials, or
planning to participate during this examination period
16. Subjects who can not agree with preliminary explanation
17. Subjects who are deemed to be unsuitable by the investigator.

Target sample size

52


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Ikuo Fukuhara

Organization

Fukuhara Clinic

Division name

Hospital director

Zip code


Address

3-1-15 Shimamatsuhigashi-machi Eniwa, Hokkaido, Japan

TEL

0123-36-8029

Email

i-feniwa@gray.plala.or.jp


Public contact

Name of contact person

1st name
Middle name
Last name endoh yoshiki

Organization

New drug research center, Inc.

Division name

Clinical Research Dept.

Zip code


Address

452-1Toiso,Eniwa-shi,Hokkaido, Japan

TEL

0123-34-0412

Homepage URL


Email

y-endoh@ndrcenter.co.jp


Sponsor or person

Institute

Maruzen Pharmaceuticals Co., Ltd.

Institute

Department

Personal name



Funding Source

Organization

Maruzen Pharmaceuticals 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


Address


Tel


Email



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 01 Month 05 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 11 Month 28 Day

Date of IRB


Anticipated trial start date

2018 Year 01 Month 09 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 12 Month 27 Day

Last modified on

2018 Year 05 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034925


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name