UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029156 |
|---|---|
| Receipt number | 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 10:13:59 |
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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
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
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
clinical@santen.co.jp
Sponsor or person
Institute
Santen Pharmaceutical Co., Ltd.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033324
