UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000029156
Receipt No. R000033324
Scientific Title Effects of a Food Containing Extract of bilberry/bulk of pine intake on ocular blood flow in healthy adults.
Date of disclosure of the study information 2018/03/10
Last modified on 2019/03/26 (Ver. 7)

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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
Last 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
1st 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