Tokyo, Nov. 17 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000054215) titled 'Effects of consumption of the test food on blood oxidized lipid in healthy Japanese' on Nov. 16.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Double blind -all involved are blinded Control - Placebo

Primary Sponsor: Institute - ORTHOMEDICO Inc.

Condition: Condition - Healthy Japanese Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To verify the effects of consumption of the test food on oxidized lipid in healthy Japanese. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Duration: 12 weeks Test food: Active food Interventions/Control_2 - Duration: 12 weeks Test food: Placebo food

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1. Japanese

2. Men or women

3. Adults

4. Healthy individuals

5. Individuals whose blood oxidized lipid level is high at screening (before consumption) Key exclusion criteria - 1. Individuals who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction

2. Individuals who have a pacemaker or an implantable cardioverter defibrillator (ICD)

3. Individuals who are currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases

4. Individuals who are taking "Foods for Specified Health Uses" or "Foods with Functional Claims"

5. Individuals who are taking or using medications (including herbal medicines) and supplements

6. Individuals who are allergic to medicines and/or the test product related products

7. Individuals who have asthma or have a medical history of asthma

8. Individuals who take the following foods or supplements on a daily basis: acai, acerola, camu-camu, smoothies, red wine, coffee, green tea drinks, oolong tea, black tea, tomato or vegetable juices, cocoa, soy milk, vitamins (such as vitamin A, vitamin C, vitamin E, or coenzyme Q10) polyphenols (such as sesamin, catechin, anthocyanin, or isoflavone), carotenoids (such as astaxanthin, lycopene, or lutein)

9. Individuals who are pregnant, lactating, or planning to become pregnant during this study

10. Individuals who have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate another study during this study

11. Individuals who are judged as ineligible to participate in this study by the physician Target Size - 20

Recruitment Status: Recruitment status - No longer recruiting Date of protocol fixation - 2024 Year 04 Month 10 Day Date of IRB - 2024 Year 04 Month 10 Day Anticipated trial start date - 2024 Year 04 Month 22 Day Last follow-up date - 2024 Year 11 Month 17 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061875

Disclaimer: Curated by HT Syndication.