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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000035171
Receipt No. R000040087
Scientific Title A study examining the effects of continuous intake of test food on eye function and QOL
Date of disclosure of the study information 2018/12/09
Last modified on 2019/06/07

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Basic information
Public title A study examining the effects of continuous intake of test food on eye function and QOL
Acronym A study examining the effects of continuous intake of test food on eye function and QOL
Scientific Title A study examining the effects of continuous intake of test food on eye function and QOL
Scientific Title:Acronym A study examining the effects of continuous intake of test food on eye function and QOL
Region
Japan

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

Objectives
Narrative objectives1 To examine improvements of eye function and QOL in healthy adults with reduced eye function after continuously taking test drink for 12 weeks.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Eye fatigue measurement (high-frequency component-1)
Key secondary outcomes Macular pigment optical density measurement, Contrast sensitivity measurement , Eye test, Subjective symptoms questionnaire to assess eye symptoms , Bowel habit questionnaire, Blood flow measurement

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 Take 20 ml of test drink daily immediately after waking up.
Interventions/Control_2 Take 20 ml of placebo daily immediately after waking up.
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
60 years-old >
Gender Male and Female
Key inclusion criteria 1.20 to 59 years old (at the time of submission of an informed consent document)
2.Healthy adults (who were judged as healthy individuals by the principal investigator)
3.Men and women
4.Those with subjective symptoms of eye fatigue
5.Non-smokers
6.Smartphone users (who can use electronic diaries)
7.Those who do not change their prescription of eyeglasses or contact lenses during the study period
8.Those who can continue to take test food for 3 months
9.Those who can provide their written informed consent
Key exclusion criteria 1.Those who currently receive some types of drug treatment (except for the drugs that are taken as needed)
2.Those who currently undergo dietary or exercise therapy under the supervision of a physician
3.Those with a history of treatment for malignant tumor, heart failure, or heart attack
4.Those who have undergone gastrointestinal surgery (except for appendectomy)
5.Those with a past medical history of any of the following: hepatic or other major disorders (kidneys, endocrine, cardiovascular, gastrointestine, lungs, blood, and metabolism), or complications of the disorders listed above
6.Those who have undergone laser-assisted in-situ keratomileusis in the past six months
7.Those with eye diseases, except for ametropia (hyperopia, myopia, and astigmatism)
8.Those who currently take health food (such as food products to maintain or restore health and supplements)
9.Those with a past and current medical history of drug or food allergy
10.Those who work irregularly, such as night shifts and irregular shifts
11.Those who have participated in another clinical trial within a month prior to submission of an informed consent document
12.Those who are currently pregnant or breastfeeding and those who desire a pregnancy
13.In the opinion of the principal investigator, those who were determined to be unsuitable for participation in this clinical trial
Target sample size 58

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuto Terai
Organization West Waseda eye Clinic
Division name Director
Zip code
Address 1-1-1, Takadanobaba , Shinjyuku, Tokyo, Japan
TEL 03-6380-2466
Email kterai@wwec.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naomi Yuzawa
Organization imeQ RD inc.
Division name Sales department
Zip code
Address 2-14-6, Nishi-Waseda, Shinjyuku, Tokyo, Japan
TEL 03-6225-6222
Homepage URL
Email n-yuzawa@imeqrd.co.jp

Sponsor
Institute imeQ RD inc.
Institute
Department

Funding Source
Organization Kotohogi Co.,Ltd.
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2018 Year 12 Month 09 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
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
2018 Year 11 Month 27 Day
Date of IRB
2018 Year 11 Month 27 Day
Anticipated trial start date
2019 Year 01 Month 07 Day
Last follow-up date
2019 Year 04 Month 18 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 12 Month 07 Day
Last modified on
2019 Year 06 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040087

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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