UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Safety evaluation of an excessive consumption of a botanical extract-formulated food - Placebo control double blind parallel group comparison clinical trial -
Title of the study (Brief title)	Safety evaluation of an excessive consumption of a botanical extract-formulated food
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 botanical extract-formulated food 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 who females 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 30kg/m2of BMI. 3. Subjects who fall under diagnostic criteria of metabolic syndrome 4. Subjects who given surgery, or taken medication due to serious illness within a month 5. Subject who present heart, liver, kidney disorders. 6. Subjects who are taking drugs, foods for specified health use or functional foods which could affect this study. 7. Subjects who Females in pregnancy, lactation and scheduled pregnancy period. 8. Subjects who with heavy use of alcohol, and heavy smoking. 9. Subject who have been felt ill by blood collection. 10. Subjects who donated 200 ml or more of blood within a month prior to the study 11.Subjects who with irregular eating habits.(Night shift worker) 12. Subjects who plan business trip or trip for 10 consecutive days or more. 13. Subjects who have allergy related to the study foods 14. Subjects who have chronic diarrhea or chronic coprostasis 15. Subjects already participating in other clinical trials, or planning to participate during this examination period 16. Subjects who can not agree with preliminary explanation 17. Subjects who are deemed to be unsuitable by the investigator.
Target sample size	52

Research contact person
Name of lead principal investigator	Ikuo Fukuhara
Organization	Fukuhara Clinic
Division name	Hospital director
Address	3-1-15 Shimamatsuhigashi-machi Eniwa, Hokkaido, Japan
TEL	0123-36-8029
Email	i-feniwa@gray.plala.or.jp

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 28 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=R000034925