UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Improvement effect of test food on Vascular endothelial function
Title of the study (Brief title)	Improvement effect of test food on Vascular endothelial function
Region	Japan

Condition
Condition	Healthy volunteer
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study aims to evaluate improvement effects on Vascular endothelial function
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	FMD after eight -weeks ingestion of test food
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	3
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Ingestion of test food (low dose) consecutively for eight weeks
Interventions/Control_2	Ingestion of control food (high dose) for eight weeks
Interventions/Control_3	Ingestion of control food for eight weeks
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	50 years-old <=
Age-upper limit	65 years-old >
Gender	Male and Female
Key inclusion criteria	1)50 to 65 years at the time of informed consent and healthy male and female
Key exclusion criteria	1)Subjects who previous or present serious disease such digestive, liver, kidney, circulatory, blood, endocrine disorder 2)Subjects who are taking medicine or being treated by a doctor 3)Subjects who are intend to undergo treatment or medication by a doctor during the test period 4)Subjects who plan to take specified healthy food, functionality food, supplement in the test period 5)Subjects who perform high exercise intensity with fatigue the next day or Manual labor 6)Night worker 7)Subjects who take excessive alcohol 8)Subjects who smoke present or have smoked within the last one year prior to the current study 9)Subjects who may cause allergic to urewa 10)Subjects who may cause symptoms of diarrhea against sugar alcohols 11)Women who are not over a year since the last menstruation 12)Women who are pregnant or may be pregnant 13)Women who are breast-feeding 14)Subjects who are planning to participate in other clinical study 15)Subjects who are judged as unsuitable for the study by the person in charge for other reason
Target sample size	90

Research contact person
Name of lead principal investigator	Kei Yui
Organization	FANCL Corporation
Division name	Research Institute
Address	Kamishinano 12-13, Totsuka-ku, Yokohama, Kanagawa,244-0806
TEL	045-820-3522
Email	tsubokawa_masaya@fancl.co.jp

Public contact
Name of contact person	Masaya Tsubokawa
Organization	FANCL Corporation
Division name	Research Institute
Address	Kamishinano 12-13, Totsuka-ku, Yokohama, Kanagawa,244-0806
TEL	045-820-3659
Homepage URL
Email	tsubokawa_masaya@fancl.co.jp

Sponsor
Institute	Medical Corporation Foundation Kenkoin Kenkoin Clinic
Institute
Department

Funding Source
Organization	FANCL Corporation
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	2017 Year 01 Month 26 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 12 Month 15 Day
Anticipated trial start date	2017 Year 01 Month 26 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	2016 Year 12 Month 29 Day
Last modified on	2017 Year 04 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029317