UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Safety evaluation of an excessive consumption of a food containing botanical extract - Placebo control double blind parallel group comparison clinical trial -
Title of the study (Brief title)	Safety evaluation of an excessive consumption of a food containing botanical extract
Region	Japan

Condition
Condition	healthy subjects
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the safety of excessive consumption of a food containing botanical extract for 4weeks
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	< Safety> Side effect incidence, Adverse event incidence, clinical examination items, physiological examination items
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	Study food 5 times of serving size per day for 4 weeks, safety evaluations are performed at 0, 2, 4 and 6 weeks
Interventions/Control_2	Control food 5 times of serving size per day for 4 weeks, safety evaluations are performed at 0, 2, 4 and 6 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 males and females who equal to or more than 20 years and less than 65 years of age 2.Subjects who can visit the medical institution at the scheduled visit date 3. Subjects who are able to understand the study and willing to provide written informed consent
Key exclusion criteria	1. Subjects who systolic blood pressure is less than 90 mmHg 2. Subjects who equal to or more than 25kg/m of BMI 3. Subjects who given surgery, or taken medication due to serious illness within a month 4. Subject who present heart, liver, kidney disorders 5. Subjects who are taking drugs, foods for specified health use or functional foods which could affect this study 6. Subjects who Females in pregnancy, lactation and scheduled pregnancy period 7 Subjects who with heavy use of alcohol, and heavy smoking 8. Subject who have been felt ill by blood collection 9. Subjects who donated 200 ml or more of blood within a month prior to the study 10 Subjects who with irregular eating habits(Night shift worker) 11. Subjects who plan business trip or trip for 10 consecutive days or more 12. Subjects who have allergy related to the test foods 13. Subjects who have chronic diarrhea or chronic coprostasis 14.Subjects who already participating in other clinical trials, or planning to participate during this examination period 15. Subjects who can not agree with prliminary explanation 16. Subjects who are deemed to be unsuitable by the investigator
Target sample size	52

Research contact person
Name of lead principal investigator	Miura Hirona
Organization	Higashi shinjuku Clinic
Division name	Hospital director
Address	1-11-3, Okubo Shinjuku-ku, Tokyo
TEL	03-6233-8583
Email	koike@meiseikai-cl.com

Public contact
Name of contact person	Endoh Yoshiki
Organization	New drug research center, Inc.
Division name	Clinical Research Dept.
Address	452-1Toiso,Eniwa-shi,Hokkaido, Japan
TEL	0123-34-0412
Homepage URL
Email	y-endoh@ndrcenter.co.jp

Sponsor
Institute	Maruzen Pharmaceuticals Co., Ltd.
Institute
Department

Funding Source
Organization	Maruzen Pharmaceuticals Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information	2018 Year 01 Month 05 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 11 Month 29 Day
Anticipated trial start date	2018 Year 01 Month 09 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 12 Month 27 Day
Last modified on	2018 Year 05 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034935