UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038180
Receipt number R000043526
Scientific Title A study to evaluate the safety of excessive intake of test food in a healthy adult subject
Date of disclosure of the study information 2019/10/02
Last modified on 2020/10/09 12:01:07

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Basic information

Public title

A study to evaluate the safety of excessive intake of test food in a healthy adult subject

Acronym

A study to evaluate the safety of excessive intake of test food in a healthy adult subject

Scientific Title

A study to evaluate the safety of excessive intake of test food in a healthy adult subject

Scientific Title:Acronym

A study to evaluate the safety of excessive intake of test food in a healthy adult subject

Region

Japan


Condition

Condition

N/A

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This study examine the safety of 4-weeks excessive ingestion of a food containing plant extracts in a healthy adult subject

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Incidence of adverse events and side effects

Key secondary outcomes

(1) Physical measurement (Body weight, Body mass index, body fat percentage)
(2) Physical examination
(3) Blood biochemical test
(4) Hematological test
(5) Urinalysis


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 Device,equipment

Interventions/Control_1

Oral intake of the test product with a plant extract (10 tablets per day; 4 weeks)

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 adult males and females from 20 to 64 years of age.
(2)Subjects who participate in this study with a written informed consent.

Key exclusion criteria

(1) Subjects who receive a drug treatment
(2) Subjects who have a history of serious disorder (heart disease, liver disease, kidney, digestive system disease, or et al.)
(3) Females who have diagnosed pregnancy or is breast-feeding
(4) Subjects who have medication or food allergy
(5) Subjects who have excessive alcohol-drinking
(6) Subjects who have extremely irregular dietary habits
(7) Subjects who are participating in other trial, have participated in the past 4 weeks, or plan to participate in other trial during scheduled period in this trial
(8) Subjects who have made a blood donation of 200 mL within the last one month prior to this study
(9) Male subjects who have made a blood donation of 400 mL within the last three months prior to this study (10) Female subjects who have made a blood donation of 400 mL within the last four months prior to this study
(11) Male subjects who have made a blood donation over an amount (1,200 mL minus the estimated volume of blood sampling during the study) within the last one year prior to this study
(12) Female subjects who have made a blood donation over an amount (800 mL minus the estimated volume of blood sampling during the study) within the last one year prior to this study
(13) Subjects judged as unsuitable for the study by the investigators

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Yoshihiro
Middle name
Last name Yamamoto

Organization

House Wellness Foods Corporation

Division name

Research and Development Institute

Zip code

664-0011

Address

Imoji 3-20, Itami, Hyogo, Japan

TEL

072-778-1127

Email

Yamamoto_Yoshihiro@house-wf.co.jp


Public contact

Name of contact person

1st name Ryusei
Middle name
Last name Uchio

Organization

House Wellness Foods Corporation

Division name

Research and Development Institute

Zip code

664-0011

Address

Imoji 3-20, Itami, Hyogo, Japan

TEL

072-778-1127

Homepage URL


Email

Uchio_Ryusei@house-wf.co.jp


Sponsor or person

Institute

Research & Development Institute, House Wellness Foods Corporation

Institute

Department

Personal name



Funding Source

Organization

House Wellness Foods Corporation

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

Institutional Review Board of Chiyoda Paramedical Care Clinic

Address

2F Sanwauchikannda Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, Japan

Tel

03-5297-5548

Email

IRB@cpcc.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

2019 Year 10 Month 02 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

2019 Year 08 Month 20 Day

Date of IRB

2019 Year 08 Month 09 Day

Anticipated trial start date

2019 Year 10 Month 07 Day

Last follow-up date

2019 Year 11 Month 04 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2019 Year 10 Month 02 Day

Last modified on

2020 Year 10 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043526


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name