UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056048 |
|---|---|
| Receipt number | R000063962 |
| Scientific Title | A Study on the Effects of Supplement Intake on Visual Function - A Randomized Double-Blind Parallel Group Comparison Trial |
| Date of disclosure of the study information | 2024/11/23 |
| Last modified on | 2025/05/29 13:20:55 |
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Basic information
Public title
A Study on the Effects of Supplement Intake on Visual Function - A Randomized Double-Blind Parallel Group Comparison Trial
Acronym
A Study on the Effects of Supplement Intake on Visual Function
Scientific Title
A Study on the Effects of Supplement Intake on Visual Function - A Randomized Double-Blind Parallel Group Comparison Trial
Scientific Title:Acronym
A Study on the Effects of Supplement Intake on Visual Function
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the impact of consuming the supplement for 4 weeks on intraocular pressure (IOP) in healthy individuals with slightly elevated IOP using a Randomized Controlled Trial (RCT).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Intraocular pressure (IOP)
Key secondary outcomes
Contrast Sensitivity
Quality of Life (QOL) Questionnaires (NEI VFQ-25, VAS, Anti-Aging QOL)
Cellular Activity
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
Participants will consume 2 capsules of the test supplement once daily with water or warm water without chewing.
Interventions/Control_2
Participants will consume 2 capsules of the placebo supplement once daily with water or warm water without chewing.
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
| 40 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Age: 40 years or older, but younger than 65 years.
2.Men and women of Japanese nationality.
3.BMI between 18.5 kg/m2 and 30.0 kg/m2.
4.IOP less than 20.0 mmHg at the time of screening.
5.Capability to enter data into an electronic diary via a smartphone or PC.
6.Individuals who have received a sufficient explanation about the study's purpose and content, fully understood it, voluntarily consented to participate and provided written consent.
Key exclusion criteria
1.Receiving treatment for any disease or taking medication (on-demand use allowed).
2.Undergoing dietary or exercise therapy under medical supervision.
3.History of eye surgery (retinal detachment, LASIK, ICL) or eye diseases, including normal-tension glaucoma.
4.Severe liver, kidney, heart, respiratory, endocrine, metabolic diseases, or history thereof.
5.History of gastrointestinal surgery (appendectomy allowed).
6.Using medications, quasi-drugs, health foods, supplements, or foods with functional claims for eye care.
7.Regularly (three or more times a week) consuming over-the-counter medications, quasi-drugs, health foods, supplements, foods for specified health uses, or foods with functional claims (participation allowed if stopped post-consent).
8.Current or past history of drug or food allergies.
9.Eye allergy symptoms from November to March (including those at risk).
10.Excessive alcohol consumption (pure alcohol intake of 40g or more per day).
11.Excessive smoking (21 or more cigarettes per day).
12.Engaged in shift work with night shifts.
13.Planning significant lifestyle changes (diet, sleep, exercise) during the study period due to long-term travel, etc.
14.History of vagal reactions or frequent anemia symptoms after blood collection.
15.Currently pregnant or breastfeeding, or planning to become pregnant during the study period.
16.Participating in other clinical trials, or within 4 weeks of this study, or planning to participate in another clinical trial post-consent.
17.Donated blood components or 200 mL of whole blood within one month before the study.
18.Donated 400 mL of whole blood within three months before the study.
19.Total blood donation volume, including this study, exceeds 1200 mL within 12 months prior.
20.Considered inappropriate for the study by the principal or sub-investigators.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Machiko |
| Middle name | |
| Last name | Nishioka |
Organization
KOBAYASHI Pharmaceutical Co.,Ltd.
Division name
R&D Department, Central R&D Laboratory
Zip code
567-0057
Address
1-30-3, Toyokawa, Ibaraki-city, Osaka, 567-0057, Japan
TEL
090-3922-5871
m.nishioka@kobayashi.co.jp
Public contact
Name of contact person
| 1st name | Yoshitada |
| Middle name | |
| Last name | Hira |
Organization
IMEQRD Co., Ltd.
Division name
Planning and Sales Department
Zip code
104-0061
Address
Daiwa Ginza Bld. 3F, 6-2-1, Ginza, Chuo-ku, Tokyo, Japan
TEL
0367045968
Homepage URL
clinical-trial@imeqrd.co.jp
Sponsor or person
Institute
IMEQRD Co. Ltd.
Institute
Department
Personal name
Funding Source
Organization
KOBAYASHI Pharmaceutical Co.,Ltd.
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
Suda Clinic institutional review board
Address
2-8-14,Takadanobaba,Shinjyuku,Tokyo
Tel
0367045968
jimukyoku@imeqrd.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
| 2024 | Year | 11 | Month | 23 | 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
| 2024 | Year | 07 | Month | 23 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 30 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 22 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 23 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 11 | Month | 05 | Day |
Last modified on
| 2025 | Year | 05 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063962
