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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000033854 |
Receipt No. | 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 |
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 |
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Condition | ||
Condition | Healthy subjects | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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. |
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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. |
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Target sample size | 62 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
Institute | HUMA R&D CORP |
Institute | |
Department |
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 |
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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 | |
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Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Completed | ||||||
Date of protocol fixation |
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Date trial data considered complete |
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Date analysis concluded |
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Other | |
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Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038572 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |