UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study of excessive intake of the food ingredient (SME-2017-08-HRCT)
Title of the study (Brief title)	A study of excessive intake of the food ingredient
Region	Japan

Condition
Condition	Not applicable
Classification by specialty	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	Incidence 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	Not applicable
Gender	Male and Female
Key inclusion criteria	1)Males and females whose age are 20<= years old 2)Subjects who are able to submit the written informed consents
Key exclusion criteria	1)Subjects who are with treatment 2)Females in pregnancy, lactation and scheduled pregnancy period 3)Subjects who are attending other studies or attended other studies within the past 4 weeks 4)Subjects who are; a)With present heart disorder, liver disorder, or kidney disorder, b)With history of cardiac disorder, c)With diabetes mellitus, or d)With allergy to the study foods 5)Subjects who habitually intake drugs, foods for specified health uses (FOSHU), functional foods, or dietary supplements 6)Subjects who are deemed to be unsuitable by the investigator
Target sample size	48

Research contact person
Name of lead principal investigator	Junichi Nakamura
Organization	Suntory MONOZUKURI Expert Limited
Division name	R&D Support Department HE Center
Address	2-3-3 Daiba, Minato-ku, Tokyo, Japan
TEL	03-5579-1277
Email	Junichi_Nakamura@suntory.co.jp

Public contact
Name of contact person	Kayo Saito
Organization	Suntory MONOZUKURI Expert Limited
Division name	R&D Support Department HE Center
Address	8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan
TEL	050-3182-0527
Homepage URL
Email	Kayo_Saito@suntory.co.jp

Sponsor
Institute	Suntory MONOZUKURI Expert Limited
Institute
Department

Funding Source
Organization	Suntory Wellness Limited
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 21 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 01 Month 12 Day
Anticipated trial start date	2018 Year 01 Month 22 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 01 Month 16 Day
Last modified on	2018 Year 07 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035198