UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033201
Receipt number R000037856
Scientific Title Safety assessment study on excessive intake of test supplement -A randomized, double blind, placebo controlled, parallel study-
Date of disclosure of the study information 2018/07/01
Last modified on 2019/01/04 09:24:32

* 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 assessment study on excessive intake of test supplement
-A randomized, double blind, placebo controlled, parallel study-

Acronym

Safety assessment study on excessive intake of test supplement

Scientific Title

Safety assessment study on excessive intake of test supplement
-A randomized, double blind, placebo controlled, parallel study-

Scientific Title:Acronym

Safety assessment study on excessive intake of test supplement

Region

Japan


Condition

Condition

Healthy volunteer

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This study aimed to verify the safety assessment on test supplement, 5-fold quantity of recommended daily intake, for consecutive 4 weeks

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Safety assessment on ingestion of test supplement, 5-fold quantity of recommended daily intake, for consecutive 4 weeks.

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

Intake of test supplement, 5-fold quantity of recommended daily intake, for 4 weeks

Interventions/Control_2

Intake of placebo, for 4 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 male and female from 20 to 65 years of age

Key exclusion criteria

1.Subjects who have judged to have problems with participation in examination due to clinical laboratory test values or cardiorespiratory abnormality
2.Subjects who are at risk of developing allergy in relation to the test supplement.
3.Subjects who have a disease requiring regular medication. Subjects who have a history of serious illness requiring medication treatment
4.Subjects whose clinical laboratory values and measured values before ingestion are significantly out of the reference range
5.Subjects who are participating in other clinical trials when start of the examination period
6.Subjects who intend to become pregnant or lactating
7.Subjects who are judged as unsuitable for the study by background survey results
8.Subjects who are judged as unsuitable for the study by the principal doctor

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kei Yui

Organization

FANCL Corporation

Division name

Research Institute

Zip code


Address

Kamishinano 12-13, Totsuka-ku, Yokohama, Kanagawa

TEL

045-820-3659

Email

tsubokawa_masaya@fancl.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Tomohiro Sugino

Organization

Soiken Inc.

Division name

Representative Director

Zip code


Address

Senri Life Science Center 13F, 1-4-2 Shin-senrihigashimachi, Toyonaka, Osaka

TEL

06-6871-8888

Homepage URL


Email

sugino@soiken.com


Sponsor or person

Institute

FANCL Corporation

Institute

Department

Personal name



Funding Source

Organization

FANCL Corporation

Organization

Division

Category of Funding Organization

Other

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 07 Month 01 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 06 Month 16 Day

Date of IRB


Anticipated trial start date

2018 Year 07 Month 21 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

2018 Year 06 Month 29 Day

Last modified on

2019 Year 01 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037856


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name