UMIN-CTR Clinical Trial

Basic information
Public title	Effects of a Food Containing Extract of bilberry/bulk of pine intake on ocular blood flow in healthy adults.
Acronym	Ocular blood flow study of bilberry/bulk of pine extracts
Scientific Title	Effects of a Food Containing Extract of bilberry/bulk of pine intake on ocular blood flow in healthy adults.
Scientific Title:Acronym	Ocular blood flow study of bilberry/bulk of pine extracts
Region	Japan

Condition
Condition	N/A (Healthy adults)
Classification by specialty	Ophthalmology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study examines effects of test food on ocular blood flow in healthy adults.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Value and rate changes of optic nerve blood flow from pre-dosing at 4, 8 and 12 weeks after dosing Adverse effect
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Oral intake of test food (1 pill in once a day, 12 weeks)
Interventions/Control_2
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 aged 20 years over [2] Individuals whose written informed consent has been obtained [3]Individuals who can have an examination in a designated day [4]Individuals without ocular disease except ametropia [5]Individuals whose ocular blood flow can stably measured
Key exclusion criteria	[1] Individuals with serious disease [2] Individuals with cigarettes smoker [3]Individuals with cardiac failure, renal failure, hepatitis B or C, Hyperlipidemia, hypotension, hypertension, diabetes or a history of the said diseases [4]Individuals who continuously used a antioxidative supplement (ex. bulk of pine extracts, bilberry, blackcurrant, rutein, astaxanthin, vitamin E) or have plan to use said supplements during the study period [5] Individuals who used a drug having influence to ocular blood flow (ex. antihypertensive agents, circulation improving drugs) in the past 4 weeks. [6] Individuals who is pregnant, lactating, or may possibly be pregnant. [7] Individuals who entry into another clinical trial, or has a history of the entry into other clinical trials within 3 months [8] Individuals with allergy to test food or who may possibly be allergy to test food, or with severe allegy to other foods or drugs. [9] Individuals who are inappropriate case judged by investigator or subinvestigators.
Target sample size	14

Research contact person
Name of lead principal investigator	1st name Masayo Middle name Last name Hashimoto
Organization	Santen Pharmaceutical Co., Ltd.
Division name	Japan Medical Affairs Group, Development Management Department, Japan Business
Zip code	530-8552
Address	4-20, Ofukacho, Kita-ku, Osaka
TEL	06-4802-9337
Email	clinical@santen.co.jp

Public contact
Name of contact person	1st name Yasutaka Middle name Last name Takagi
Organization	Santen Pharmaceutical Co., Ltd.
Division name	Japan Medical Affairs Group, Development Management Department, Japan Business
Zip code	530-8552
Address	4-20, Ofukacho, Kita-ku, Osaka
TEL	06-4802-9337
Homepage URL
Email	clinical@santen.co.jp

Sponsor
Institute	Santen Pharmaceutical Co., Ltd.
Institute
Department

Funding Source
Organization	Santen 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	Kitasato University IRB
Address	1-15-1 Kitasato, Minami, Sagamihara, Kanagawa, 252-0375, Japan
Tel	042-778-8273
Email	rinrib@med.kitasato-u.ac.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	北里大学病院（Kitasato University Hospital）

Other administrative information
Date of disclosure of the study information	2018 Year 03 Month 10 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	14
Results	In this few cases study,the significant increase in ocular blood flow was not observed.
Results date posted	2019 Year 03 Month 26 Day
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	2017 Year 09 Month 13 Day
Date of IRB	2017 Year 11 Month 02 Day
Anticipated trial start date	2018 Year 03 Month 01 Day
Last follow-up date	2019 Year 01 Month 25 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 09 Month 15 Day
Last modified on	2019 Year 03 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033324

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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