Tokyo, Oct. 11 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059368) titled 'Effect of Test Food Consumption on Visual Function and Its Safety.
-Randomized, double-blind, placebo-controlled crossover comparative trial-' on Oct. 11.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - TES Holdings Co., Ltd.
Condition:
Condition - No
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - This study evaluates the effects on visual function and safety resulting from continuous consumption of the test food.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - [1] Oral ingestion of a test food (2 tablets in a day; 2 weeks).
[2] Observation.
[3] Washout (2weeks).
[4] Oral ingestion of a placebo food (2 tablets in a day; 2 weeks).
[5] Observation.
Interventions/Control_2 - [1] Oral ingestion of a placebo food (2 tablets in a day; 2 weeks).
[2] Observation.
[3] Washout (2weeks).
[4] Oral ingestion of a test food (2 tablets in a day; 2 weeks).
[5] Observation.
Eligibility:
Age-lower limit - 20
years-old
Gender - Male and Female
Key inclusion criteria - 1) Japanese males and females aged 20-64 years.
2) Individuals who are healthy and are not received treatment of disease.
3) Individuals who have binocular vision of 0.7 or better with naked eye or corrected vision, and who do not wear contact lenses.
4) Individuals whose written informed consent has been obtained.
5) Individuals who can come to the designated venue for this study and be inspected.
6) Individuals judged appropriate for the study by the principal.
Key exclusion criteria - 1) Individuals using medical products.
2) Individuals with a history or current condition of serious disorders affecting the eyes, digestive organs, liver, kidneys, heart, lungs, blood, or mental health.
3) Individuals who used a drug to treat a disease in the past 1 month.
4) Individuals who use intraocular lens.
5) Individuals with presbyopia or age-related farsightedness who use reading glasses.
6) Individuals whose BMI is over 30 kg/m2.
7) Individuals with drug and food allergies.
8) Individuals who currently have, or have had within the past three months, a habit of regularly consuming functional foods, health foods, or supplements that claim to improve eye-related functions, or that contain maqui berry, bilberry, blackcurrant, anthocyanin, or other active ingredients expected to have beneficial effects on the eyes; as well as individuals who plan to consume such products during the trial period.
9) Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60g/day).
10) Individuals with possible changes of life style during the test period.
11) Individuals who engage in a night work.
12) Individuals who are or are possibly pregnant, or are lactating.
13) Individuals who participated in other clinical studies in the past 3 months.
14) Individuals who are or whose family is engaged in healthy or functional foods.
15) Individuals who are unable to follow instructions from the study supervisor or who judged inappropriate for the study by the principal.
Target Size - 36
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 09 Month 24 Day
Date of IRB - 2025 Year 09 Month 25 Day
Anticipated trial start date - 2025 Year 11 Month 02 Day
Last follow-up date - 2025 Year 12 Month 26 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067745
Disclaimer: Curated by HT Syndication.
