Unique ID issued by UMIN | UMIN000035171 |
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Receipt number | 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 | 2021/02/16 19:08:08 |
A study examining the effects of continuous intake of test food on eye function and QOL
A study examining the effects of continuous intake of test food on eye function and QOL
A study examining the effects of continuous intake of test food on eye function and QOL
A study examining the effects of continuous intake of test food on eye function and QOL
Japan |
Healthy adults
Adult |
Others
NO
To examine improvements of eye function and QOL in healthy adults with reduced eye function after continuously taking test drink for 12 weeks.
Safety,Efficacy
Eye fatigue measurement (high-frequency component-1)
Macular pigment optical density measurement, Contrast sensitivity measurement , Eye test, Subjective symptoms questionnaire to assess eye symptoms , Bowel habit questionnaire, Blood flow measurement
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Prevention
Food |
Take 20 ml of test drink daily immediately after waking up.
Take 20 ml of placebo daily immediately after waking up.
20 | years-old | <= |
60 | years-old | > |
Male and Female
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
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
58
1st name | Kazuto |
Middle name | |
Last name | Terai |
West Waseda eye Clinic
Director
169-0075
1-1-1, Takadanobaba , Shinjyuku, Tokyo, Japan
03-6380-2466
kterai@wwec.jp
1st name | Naomi |
Middle name | |
Last name | Yuzawa |
IMEQRD Co., Ltd
Sales department
104-0061
6-2-1 Ginza Chuo-ku Tokyo Japan
03-6704-5968
n-yuzawa@imeqrd.co.jp
IMEQRD Co., Ltd
Kotohogi Co.,Ltd.
Self funding
Suda Clinic institutional review board
2-8-14,Takadanobaba,Shinjyuku,Tokyo
03-6704-5968
n-yuzawa@imeqrd.co.jp
NO
2018 | Year | 12 | Month | 09 | Day |
Unpublished
Completed
2018 | Year | 11 | Month | 27 | Day |
2018 | Year | 11 | Month | 27 | Day |
2019 | Year | 01 | Month | 07 | Day |
2019 | Year | 04 | Month | 18 | Day |
2018 | Year | 12 | Month | 07 | Day |
2021 | Year | 02 | Month | 16 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040087
Research Plan | |
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