UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035920 |
|---|---|
| Receipt number | R000040872 |
| Scientific Title | Study on the improvement of ocular function by continuous ingestion of food |
| Date of disclosure of the study information | 2019/02/18 |
| Last modified on | 2019/10/16 14:57:38 |
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Basic information
Public title
Study on the improvement of ocular function by continuous ingestion of food
Acronym
Study on the improvement of ocular function by continuous ingestion of food
Scientific Title
Study on the improvement of ocular function by continuous ingestion of food
Scientific Title:Acronym
Study on the improvement of ocular function by continuous ingestion of food
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 the improvement of ocular function in men and women aged 20 years or older, 69 years or younger, who have received the test food continuously for 16 weeks.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Macular pigment optical density
Key secondary outcomes
Accommodative power
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
16-week intake of the test food
Interventions/Control_2
16-week intake of the placebo food
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
| 69 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Japanese males and females aged 20 to 69 years old or younger at the time of obtaining informed consent
2)Patients who have a BMI 25 kilogram/m2 or less
3) Subjects with uncorrected or corrected visual acuity of 0.7 or higher for both eyes
4)Persons who have not undergone LASIK surgery(myopia correction surgery)
5)Persons who are regularly aware of eye fatigue
6)Those who can stop eye drops for astigmatism improvement during the test period
7)Persons who can be contacted by personal computers or smartphones
8)Those who were fully informed of the purpose and content of the study, were able to give consent, voluntarily volunteered to participate in the study, and agreed to participate in the study in writing.
Key exclusion criteria
1)Patients who are currently receiving any medication or outpatient treatment
2)Subjects currently undergoing exercise or diet therapy under the supervision of a physician.
3)Persons who are likely to develop allergies from test foods
4)People with pollinosis
5)Patients with current or past history of drug dependence or alcohol dependence
6)Patients who have been attending the hospital with psychiatric disorders (depression, etc.) or sleep disorders, or who have a history of psychiatric disorders in the past
7)Night or shift workers
8)Person who is extremely irregular in lifestyle such as eating and sleeping
9)Persons engaging in extreme prey
10)Patients with a current or past history of serious diseases such as diabetes mellitus, liver disease (hepatitis), renal disease, heart disease, etc., thyroid disease, adrenal disease, or other metabolic diseases.
11)Patients with ocular diseases other than refractive errors (hyperopia, myopia, astigmatism)
12)Persons with eyelashes extension
13)Persons who use health foods, supplements, and drugs that affect eye function.
14)Those who participated in another clinical study (study) within 3 months after the date of informed consent, or who are planned to participate in another clinical study (study) during the study period.
15)A blood sample exceeding 200 ml within 3 months or 400 ml within 3 months after the date of obtaining informed consent or a component blood donation.
16)Subjects who are currently pregnant or breast-feeding, or who may be pregnant or breastfeeding during the study period.
17)Current smokers or those who smoked within the past year
18)Persons who have difficulty complying with the records of various surveys
19)Subjects who are determined to be ineligible based on laboratory values and measurements at the time of SCR.
20)Other persons for whom the principal investigator judges to be inappropriate as subjects of the study.
Target sample size
60
Research contact person
Name of lead principal investigator
| 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
ochitani@huma-rd.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
Limited company mycare
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
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
60
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 | 12 | Day |
Last follow-up date
| 2019 | Year | 06 | Month | 14 | Day |
Date of closure to data entry
| 2019 | Year | 06 | Month | 21 | Day |
Date trial data considered complete
| 2019 | Year | 07 | Month | 10 | Day |
Date analysis concluded
| 2019 | Year | 09 | Month | 25 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 02 | Month | 18 | Day |
Last modified on
| 2019 | Year | 10 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040872
