UMIN-CTR Clinical Trial

Basic information
Public title	Safety confirmation test of overdose intake of foods containing Camellia Japonica seed extract
Acronym	Safety confirmation test of overdose intake of foods containing Camellia Japonica seed extract
Scientific Title	Safety confirmation test of overdose intake of foods containing Camellia Japonica seed extract -open-label trial-
Scientific Title:Acronym	Safety confirmation test of overdose intake of foods containing Camellia Japonica seed extract -open-label trial-
Region	Japan

Condition
Condition	Healthy adult
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To identify the safety of excessive the test foods to consume 5 times of normal daily intake for 4 weeks in healthy Japanese subjects.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Body measurement, physical examination Hematology test Blood biochemistry test Urinalysis Doctor's questions Assess these at screening (before intake), at 2 and 4 weeks after intake.
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	Intake of test foods for 4 consecutive weeks (10 capsules/ day)
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) Healthy adult males and females between 20 to 64 years (2) BMI: less than 30 kg/m2 (3) Subjects who have received sufficient explanation about the purpose and content of the examination, have the ability to consent, have a good understanding, volunteered to participate and agreed to participate in the examination in writing
Key exclusion criteria	(1) Subjects who were diagnosed with liver disease, kidney disease, gastrointestinal disease, heart disease, diabetes, or other diseases that may affect the results of this study, or who have a history of surgery (2) Subjects who indicate abnormal parameter in liver or kidney function (3) Subjects with a disease currently under treatment (4) Subjects with anemia (5) Subjects who detect abnormal values by blood test (6) Subjects who determine ineligible by principal investigator (7) Subjects with drug or food allergies (8) Subjects who play high intensity sports and/or are on a diet (9) Subjects who can't stop using functional foods (including Food for Specified Health Uses or Foods with Function Claims) and/or Specified quasi-drugs during the current study periods (10) Subjects who are under treatment with medications (including OTC or prescribed medication) (11) Subjects who drink excessive alcohol, or who can't stop drinking from one day before each measurement (12) Subjects with smoking habit (13) Subjects with irregular life patterns and lifestyle of reversal of day and night (14) Subjects who have a habit of excessive eating and drinking (15) Subject who has been pregnant or subject who have a plan to become pregnant or breast feed during the study period (16) Subjects who is participating in the other study or planning to participate during the study period (17) Subjects who has taken the blood sampling more than 200 mL within 1 month, or plan the blood sampling during the study period
Target sample size	20

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	9F Higashitenma building, 1-7-17 Higashitenma, Kita-ku, Osaka, Osaka, Japan
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	4F Higashitenma building, 1-7-17 Higashitenma, Kita-ku, Osaka, Osaka, Japan
TEL	06-4801-8917
Homepage URL
Email	mterashima@oneness-sup.co.jp

Sponsor
Institute	Oneness support Co., Ltd.
Institute
Department

Funding Source
Organization	BHN 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	Miura Clinic, Medical Corporation Kanonkai IRB
Address	9F Higashitenma building, 1-7-17 Higashitenma, Kita-ku, Osaka, Osaka, Japan
Tel	06-6135-5200
Email	mterashima@oneness-sup.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 04 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 09 Month 27 Day
Date of IRB	2019 Year 10 Month 03 Day
Anticipated trial start date	2019 Year 10 Month 14 Day
Last follow-up date	2019 Year 12 Month 09 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 01 Day
Last modified on	2020 Year 04 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043466