UMIN-CTR Clinical Trial

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
Institute	Research & Development Institute, House Wellness Foods Corporation
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043526