UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033854 |
|---|---|
| Receipt number | R000038572 |
| Scientific Title | A randomized, placebo-controlled, double-blind, parallel-group trial of the improvement in ocular function with continued lutein intake |
| Date of disclosure of the study information | 2018/09/04 |
| Last modified on | 2019/05/13 17:54:37 |
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Basic information
Public title
A randomized, placebo-controlled, double-blind, parallel-group trial of the improvement in ocular function with continued lutein intake
Acronym
A randomized, placebo-controlled, double-blind, parallel-group trial of the improvement in ocular function with continued lutein intake
Scientific Title
A randomized, placebo-controlled, double-blind, parallel-group trial of the improvement in ocular function with continued lutein intake
Scientific Title:Acronym
A randomized, placebo-controlled, double-blind, parallel-group trial of the improvement in ocular function with continued lutein intake
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 evaluate the effect of the study food containing lutein on ocular function in healthy Japanese men and women aged 20 years or older and 69 years or younger who continue to consume the food for 16 weeks.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Macular pigment optical density
Key secondary outcomes
Serum lutein concentration, contrast sensitivity
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
16-week intake of the containing lutein food of 2 capsules a day
Interventions/Control_2
16-week intake of the placebo food of 2 capsules 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
| 20 | years-old | <= |
Age-upper limit
| 69 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Healthy Japanese men and women aged 20 to 69 years at the time of informed consent
2)Persons with a BMI 25 kg of less than or equal to m2
3)Patients who have not undergone LASIK surgery (myopia correction surgery)
4)Patients with 0.7 or more corrected visual acuity in both eyes
5)Persons who can be contacted by personal computer or smartphone
6)Patients who can discontinue ophthalmic solutions during the study period.
7)A person who has received sufficient explanation on the purpose and content of the research, who has the ability to give consent, who voluntarily volunteers to participate in the research with a good understanding, and who has given written consent to participate in the research.
Key exclusion criteria
1)A person who is currently receiving any drug treatment or ambulatory treatment.
2)A person who is currently exercising or taking diet under the supervision of a physician.
3)Patients with a history of, present disease, or complication of liver disease or serious renal, endocrine, cardiovascular, gastrointestinal, pulmonary, hematologic, or metabolic disease.
4)Patients with chronic diseases (arrhythmias, hepatic disorders, renal disorders, cerebrovascular disorders, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or other chronic diseases) who are being treated or have a history
5)Patients who have undergone gastrointestinal surgery (appendicitis is acceptable)
6)Patients with eye diseases other than refractive error (hyperopia, myopia, astigmatism)
7)Persons with a history of drug or food allergy
8)People who wish to do so during pregnancy, lactation, or the duration of the study
9)Persons who have received blood donations or immunizations within the last 3 months or who plan to receive them during the study period.
10)Persons who routinely consume health foods, supplements, and pharmaceuticals that may affect ocular function.
11)Persons with psychiatric disorders (depression, etc.) or sleep disorders who are attending hospital or who have a history of psychiatric illness in the past
12)Alcoholics, addicts, or abusers with or without a history of treatment
13)Persons who work on a shift basis, such as those who work at night
14)Persons with extremely irregular lifestyle habits such as diet and sleep
15)Current smokers
16)Currently participating in other clinical trials or participating in other clinical trials within the last 3 months of the date of informed consent
17)Persons with difficulties in observing records on various questionnaires
18)Other persons who are judged by the investigator to be inappropriate for the study.
Target sample size
62
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
Oekkusu Bldg10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL
81-3-3431-1260
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
| 2018 | Year | 09 | Month | 04 | 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
62
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 | 08 | Month | 10 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 13 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 05 | Day |
Last follow-up date
| 2019 | Year | 01 | Month | 19 | Day |
Date of closure to data entry
| 2019 | Year | 01 | Month | 21 | Day |
Date trial data considered complete
| 2019 | Year | 02 | Month | 06 | Day |
Date analysis concluded
| 2019 | Year | 05 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 08 | Month | 22 | Day |
Last modified on
| 2019 | Year | 05 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038572
