UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035908 |
|---|---|
| Receipt number | R000040886 |
| Scientific Title | A randomized, placebo-controlled, double-blind, parallel-group trial of observations of subjective and objective symptoms of eye fatigue and testing for improvement with the ingestion of bilberry extract |
| Date of disclosure of the study information | 2019/02/18 |
| Last modified on | 2019/05/14 09:21:47 |
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Basic information
Public title
A randomized, placebo-controlled, double-blind, parallel-group trial of observations of subjective and objective symptoms of eye fatigue and testing for improvement with the ingestion of bilberry extract
Acronym
A randomized, placebo-controlled, double-blind, parallel-group trial of observations of subjective and objective symptoms of eye fatigue and testing for improvement with the ingestion of bilberry extract
Scientific Title
A randomized, placebo-controlled, double-blind, parallel-group trial of observations of subjective and objective symptoms of eye fatigue and testing for improvement with the ingestion of bilberry extract
Scientific Title:Acronym
A randomized, placebo-controlled, double-blind, parallel-group trial of observations of subjective and objective symptoms of eye fatigue and testing for improvement with the ingestion of bilberry extract
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to investigate the effect of the test food on eye function in healthy Japanese men and women aged 25 years or older and 40 years or younger who have continued to consume the test food for 4 weeks.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visual fatigue
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
4-week intake of the containing bilberry extract food of 1 capsule a day
Interventions/Control_2
4-week intake of the placebo food of 1 capsule a day
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
| 25 | years-old | <= |
Age-upper limit
| 40 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Healthy Japanese men and women aged 25 to 40 years
2) People who feel tired of their eyes
3) Persons who routinely perform PC (PC) tasks or driving a car
4) Persons who have not undergone LASIK surgery (myopia correction surgery)
5) Subjects with uncorrected visual acuity of 0.2 or better at both eyes.
6) Persons who can be contacted by personal computers or smartphones
7) Persons with a BMI of 25 kg/m2 or less
8) People who can play games with smartphones for about 30 minutes
9) Subjects who are able to discontinue eye drops during the study period"
Key exclusion criteria
1) Patients who are currently receiving any medications or outpatient
2) Subjects currently undergoing exercise or diet therapy under the supervision of a physician
3) Persons with a history or current disease or complication of liver disease or serious diseases of renal, endocrine, cardiovascular, gastrointestinal, pulmonary, hematological, or metabolic origin.
4) Persons who have been treated or had a history of chronic disease (arrhythmia, liver, kidney, cerebrovascular disease, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or other chronic diseases)
5) Persons who have had surgery of the digestive tract (appendicitis is allowed)
6) People who have pollinosis
7) Patients with ocular diseases other than refractive errors (hyperopia, myopia, astigmatism)
8) Persons with a history of drug allergy or food allergy
9) Those who wish to do so during pregnancy, lactation, or the study period.
10) Those who have received blood donations or vaccinations within the previous three months or who are scheduled to do so during the study period.
11) Persons who regularly consume health foods, supplements, and medicines that may affect eye function.
12) Persons who are in hospital due to mental disorders (depression etc.), sleeping disorders, etc., or who have a past medical history in the past.
13) Persons who are under treatment or have a history of alcohol dependence, drug dependence or drug abuser.
14) Person who is in shift work such as night work
15) Extremely irregular lifestyle, such as eating and sleeping
16) Current smokers
17) Subjects who have participated in other clinical trials or are currently participating in other clinical trials within the past 3 months of the date of informed consent.
18) Persons who have difficulty complying with the records of various surveys
19) Other persons for whom the principal investigator judges it inappropriate for the study.
"
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | Kosehira |
| Middle name | |
| Last name | Marie |
Organization
Omnica Co.,Ltd
Division name
Research and development Dept.
Zip code
112-0002
Address
TN Koishikawa BLDG. 5F, 1-15-17 Koishikawa, Bunkyo-ku, Tokyo, JAPAN
TEL
03-5840-9815
kosehira@omnica.co.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Ochitani |
Organization
HUMA R&D CORP
Division name
Clinical Development Division
Zip code
108-0014
Address
Round Cross Tamachi 10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL
03-3431-1260
Homepage URL
ochitani@huma-rd.co.jp
Sponsor or person
Institute
HUMA R&D CORP
Institute
Department
Personal name
Funding Source
Organization
Omnica Co.,Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committees of Nihonbashi Egawa Clinic
Address
2F Kotobuki Build. 1-27-12 Yaesu Chuo-ku, Tokyo 103-0028 Japan
Tel
03-5204-0311
jim@medipharma.co.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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 02 | Month | 18 | 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
37
Results
Results date posted
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
| 2019 | Year | 01 | Month | 11 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 15 | Day |
Anticipated trial start date
| 2019 | Year | 02 | Month | 14 | Day |
Last follow-up date
| 2019 | Year | 04 | Month | 06 | Day |
Date of closure to data entry
| 2019 | Year | 04 | Month | 08 | Day |
Date trial data considered complete
| 2019 | Year | 04 | Month | 28 | Day |
Date analysis concluded
| 2019 | Year | 08 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 02 | Month | 18 | Day |
Last modified on
| 2019 | Year | 05 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040886
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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