UMIN-CTR Clinical Trial

Basic information
Public title	A study of excessive intake of the food containing plant-derived ingredient. (SME-2019-02-FOSHUS)
Acronym	A study of excessive intake of the food containing plant-derived ingredient.
Scientific Title	A study of excessive intake of the food containing plant-derived ingredient. (SME-2019-02-FOSHUS)
Scientific Title:Acronym	A study of excessive intake of the food containing plant-derived ingredient.
Region	Japan

Condition
Condition	Not applicable
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the safety of food
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Expression rate of side effects
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	Four weeks repeated intake of the test foods
Interventions/Control_2	Four weeks repeated intake of the control foods
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 male and female whose age are 20 <= years old <65. (2)Subjects who are able to visit medical institution on the stipulated date. (3)Subjects who are able to submit the written informed consents.
Key exclusion criteria	(1) Subjects who are with treatment. (2) Subjects whose systolic pressure <90 mmHg. (3) Females in pregnancy,lactation and scheduled pregnancy period. (4) Subjects who donated over 200ml blood components or whole blood within 4 weeks. (5) Male Subjects who donated over 400ml whole blood within 12 weeks. (6) Female who donated over 400ml whole blood within 16 weeks. (7) Male subjects whose blood was collected more than 1200 mL within the last twelve months when the amount of blood sampling in the current study is added. (8) Female subjects whose blood was collected more than 800 mL within the last twelve months when the amount of blood sampling in the current study is added. (9) Subjects who are participating in other clinical studies, or who finished clinical study within 4 weeks. (10) Subjects who are; (a)With present heart disorder,liver disorder,or kidney disorder. (b)With history of cardiac disorder. (c)With diabetes mellitus. (d)With allergy to drugs or foods. (e)With glaucoma. (f)With hyponatremia. (11) Subjects who constantly use supplements and/or functional foods (including Food for Specified Health Uses) affecting the test results. (12) Subjects who drink alcohol or smoke a lot. (13) Subjects who have an extremely irregular diet habit or alternative work schedule or work on midnight shift. (14) Subjects who themselves or family living together work at a company that plans, researches, develops, manufactures or sells supplements and/or functional foods (including Food for Specified Health Uses). (15) Subjects who are deemed to be unsuitable by the investigator.
Target sample size	48

Research contact person
Name of lead principal investigator	1st name Hidenori Middle name Last name Obata
Organization	Suntory MONOZUKURI Expert Limited
Division name	R&D Support Department, HE Center
Zip code	135-8631
Address	2-3-3 Daiba, Minato-ku, Tokyo, Japan
TEL	03-5579-1277
Email	Hidenori_Obata@suntory.co.jp

Public contact
Name of contact person	1st name Keisuke Middle name Last name Yasumoto
Organization	Suntory MONOZUKURI Expert Limited
Division name	R&D Support Department, HE Center
Zip code	619-0284
Address	8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan
TEL	0774-66-1110
Homepage URL
Email	Keisuke_Yasumoto@suntory.co.jp

Sponsor
Institute	Suntory MONOZUKURI Expert Limited
Institute
Department

Funding Source
Organization	Suntory Beverage & Food Limited
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	Institutional Review Board of Takara Clinic
Address	2-3-2 Higashigotanda, Shinagawa-ku, Tokyo, Japan
Tel	03-5793-3623
Email	info@takara-clinic.com

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 07 Month 29 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 07 Month 29 Day
Date of IRB	2019 Year 07 Month 29 Day
Anticipated trial start date	2019 Year 07 Month 30 Day
Last follow-up date	2019 Year 12 Month 15 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 07 Month 29 Day
Last modified on	2020 Year 11 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042773