UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The verification study for safety evaluation of test food overdose in humans: an open-label trial
Title of the study (Brief title)	The verification study for safety evaluation of test food overdose in humans
Region	Japan

Condition
Condition	Healthy adults or prone to be constipated
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To identify the safety of overdose the test food for 4 weeks
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	1. Body measuring / Physical examination 2. Medical examination 3. Blood test 4. Urinalysis 5. Questionnaire (the Likert scale method) 6. The Japanese version of Constipation Assessment Scale MT version (CAS-MT) 7. Bowel movement diary 8. Dental examination *Above 1-6, conduct examinations and tests at 0 week and at 2 and 4 weeks after the ingestion and at follow-up period 2 weeks *Above 7, record when defecating *Above 8, conduct examinations at 0 week and at follow-up period 2 weeks
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	NO
Dynamic allocation	NO
Institution consideration
Blocking	NO
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Duration: 4 weeks Follow-up duration: 2 weeks Eat six of test foods per day any time
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Japanese adults 2. Those who are healthy or who have 2-5 times of defecation per week 3. Those who are considered as appropriate for the study by the physician and dentist
Key exclusion criteria	1. At least one previous medical history or under the treatment of malignant tumor, heart failure or myocardial infarction 2. Currently under the treatment for either cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension or other chronic diseases 3. Currently taking medicines and/or herbal medicines 4. Those who are allergic to medicines, milk, beans, orange, and/or other food products 5 Those who are pregnant, breast-feeding, and plan to become a pregnant 6. Those who had participated another clinical test for three months when you signed the informed consent form for this trial 7. Others considered as inappropriate for the study by the physician
Target sample size	52

Research contact person
Name of lead principal investigator	Kazuo YAMAMOTO
Organization	ORTHOMEDICO Inc.
Division name	CEO
Address	2F Sumitomo Fudosan Korakuen Bldg., 1-4-1 Koishikawa, Bunkyo-ku, Tokyo.
TEL	03-3818-0610
Email	kazu@orthomedico.jp

Public contact
Name of contact person	Naoko SUZUKI
Organization	ORTHOMEDICO Inc.
Division name	R&D Department
Address	2F Sumitomo Fudosan Korakuen Bldg., 1-4-1 Koishikawa, Bunkyo-ku, Tokyo.
TEL	03-3818-0610
Homepage URL
Email	nao@orthomedico.jp

Sponsor
Institute	ORTHOMEDICO Inc.
Institute
Department

Funding Source
Organization	KANRO CO.,LTD.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Seishin-kai Medical Association Inc, Takara Medical Clinic.
Name of secondary funｄer(s)

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	医療法人社団 盛心会 タカラクリニック (東京都) Seishin-kai Medical Association Inc, Takara Medical Clinic (Tokyo)

Other administrative information
Date of disclosure of the study information	2018 Year 03 Month 17 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 03 Month 13 Day
Anticipated trial start date	2017 Year 03 Month 17 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 03 Month 16 Day
Last modified on	2017 Year 10 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030508