Tokyo, July 16 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062132) titled 'A Study on the Effects of a Test Food on Intraocular Pressure in Healthy Adults' on July 16.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - IMEQRD Co. Ltd.
Condition:
Condition - Healthy adults
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate the effect of 8-week continuous intake of the test food on intraocular pressure in middle-aged and older adults with relatively high intraocular pressure, using a randomized, placebo-controlled trial.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Participants will consume 3 tablets of the test supplement once daily with water or warm water without chewing.
Interventions/Control_2 - Participants will consume 3 tablets of the placebo supplement once daily with water or warm water without chewing.
Eligibility:
Age-lower limit - 50
years-old
Gender - Male and Female
Key inclusion criteria - 1.Age 50 to under 65 years at consent
2.Japanese men and women
3.IOP less than 20.0 mmHg at the time of screening
4.Capability to enter data into an electronic diary via a smartphone or PC
5.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.BMI =30.0 kg/m^2
4.Eye allergy symptoms from July to December (including those at risk)
5.History of eye surgery (retinal detachment, LASIK, ICL) or eye diseases, including normal-tension glaucoma.
6.Severe liver, kidney, heart, respiratory, endocrine, metabolic diseases, or history thereof.
7.History of gastrointestinal surgery (appendectomy allowed).
8.Using medications, quasi-drugs, health foods, supplements, or foods with functional claims for eye care.
9.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)
10.Current or history of drug or food allergies.
11.Excessive alcohol consumption (pure alcohol intake of 40 g or more per day)
12.Excessive smoking (21 or more cigarettes per day).
13.Extremely irregular diet or lifestyle, shift/night workers with irregular routines
14.Plans to significantly change lifestyle (diet, sleep, exercise) during the study
15.Plans for overseas travel during the study
16.Currently pregnant, breastfeeding, or planning pregnancy during the study
17.Symptoms of anemia
18.Donated blood components or 200 mL of whole blood within one month, or 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.Participation in another clinical study within 1 month before consent, currently participating, or planning to participate during the study
21.Deemed unsuitable for participation by the principal investigator
Target Size - 64
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 06 Month 16 Day
Anticipated trial start date - 2026 Year 10 Month 15 Day
Last follow-up date - 2026 Year 12 Month 11 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071095
Disclaimer: Curated by HT Syndication.
