UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study to evaluate the safety of test foods for healthy adults.
Title of the study (Brief title)	A study to evaluate the safety of test foods.
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 ingestion of test foods for 4 weeks.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Physical, Hematologic, Blood biochemical, Urinalysis, Doctor' s questions, Weight before and 2, 4 weeks after intake and 2 weeks after the end of intake period and Adverse events thorough the study.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	4
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Intake of test food 175 mg per day for 4 consecutive weeks
Interventions/Control_2	Intake of test food 350 mg per day for 4 consecutive weeks
Interventions/Control_3	Intake of test food 700 mg per day for 4 consecutive weeks
Interventions/Control_4	Intake of test food 1050 mg per day for 4 consecutive weeks
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	Healthy males and females aged 20-64 years old
Key exclusion criteria	1.Subjects who constantly use health food richly containing involvement ingredient 2.Subjects who have serious illness such as diabetes, liver disease, kidney disease, heart disease 3.Subjects who have possibilities for emerging allergy onset related to the study 4.Subjects with chronic illness or medication 5.Subjects with an irregular diet habit 6.Subjects who are judged as unsuitable for the study from clinical measurements for preliminary tests and measurements 7.Subjects who have participated in other clinical study within the last one month or have plan to participate other clinical studies 8.Subjects who intend to become pregnant or lactating 9.Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire 10.Subjects who are judged as ineligible by clinical investigator
Target sample size	40

Research contact person
Name of lead principal investigator	Yasuhiro Sato
Organization	Shiratori Pharmaceutical Co., Ltd.
Division name	Research and Development Dept
Address	6-11-24 Tsudanuma, Narashino-city, Chiba-pref
TEL	047-453-2500
Email	y-sato@shiratori-pharm.co.jp

Public contact
Name of contact person	Kotoha Isobe
Organization	TTC Co., Ltd.
Division name	Clinical Research Planning Department
Address	Seibu Shinkin Bank Ebisu Bldg.,1-20-2, Ebisunishi, Shibuya-ku, Tokyo
TEL	03-5459-5329
Homepage URL
Email	k.isobe@ttc-tokyo.co.jp

Sponsor
Institute	TTC Co., Ltd.
Institute
Department

Funding Source
Organization	Shiratori Pharmaceutical 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 06 Month 14 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 06 Month 14 Day
Anticipated trial start date	2018 Year 06 Month 15 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	2018 Year 06 Month 14 Day
Last modified on	2018 Year 09 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037627