UMIN-CTR Clinical Trial

Basic information
Public title	Safety evaluation
Acronym	Safety evaluation
Scientific Title	Safety evaluation of excessive intake of food containing test foods for healthy adults
Scientific Title:Acronym	Safety evaluation of excessive intake of food containing test foods
Region	Japan

Condition
Condition	Healthy adult
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 through 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	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Intake of 0.85 g of test food per day for 4 consecutive weeks
Interventions/Control_2	Intake of 4.25 g of test food per day for 4 consecutive 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	64 years-old >=
Gender	Male and Female
Key inclusion criteria	Males and females from 20 to 64 years of age
Key exclusion criteria	(1) Subjects who constantly use health food richly containing involvement ingredient (2) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire (3) Subjects having a disease requiring treatment or a history of serious diseases for which medication was required (4) Who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination (5) Subjects having possibilities for emerging allergy related to the study (6) Those with diseases that require constant medication or a history of serious diseases for which medication was required (7) Subjects who have participated in other clinical study within the last one month prior to the current study or are planned to participate in other clinical study after informed consent for the current study (8) Subjects who intend to become pregnant or lactating (9) Subjects judged as unsuitable for the study by the investigator for other reasons
Target sample size	20

Research contact person
Name of lead principal investigator	1st name atsushi Middle name Last name higashi
Organization	Shiratori Pharmaceutical Co., Ltd.
Division name	Research and Development Dept
Zip code	275-0016
Address	6-11-24 Tsudanuma, Narashino-city, Chiba-pref
TEL	047-453-2500
Email	atsushi-higashi@shiratori-pharm.co.jp

Public contact
Name of contact person	1st name Yuka Middle name Last name Sato
Organization	TTC Co., Ltd.
Division name	Clinical Research Planning Department
Zip code	150-0021
Address	Seibu Shinkin Bank Ebisu Bldg.,1-20-2, Ebisunishi, Shibuya-ku, Tokyo
TEL	03-5459-5329
Homepage URL
Email	y.sato@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)

IRB Contact (For public release)
Organization	Aisei Hospital Ueno Clinic Research Ethics Committee
Address	2-18-6, Higashiueno, Taitou-ku, Tokyo
Tel	03-6455-0880
Email	t.saito@ttc-smo.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 09 Month 12 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 08 Month 08 Day
Date of IRB	2019 Year 08 Month 09 Day
Anticipated trial start date	2019 Year 09 Month 13 Day
Last follow-up date	2019 Year 11 Month 14 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 09 Month 12 Day
Last modified on	2019 Year 11 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043311