Tokyo, Nov. 29 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000056335) titled 'A study to evaluate the safety of excessive consumption of the test food' on Nov. 29.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - ORTHOMEDICO Inc.

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

Objective: Narrative objectives1 - To verify the safety of consuming the capsule containing docosahexaenoic acid (DHA) Basic objectives2 - Safety

Intervention: Interventions/Control_1 - Duration: Four weeks Test food: Capsule containing DHA

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 Key exclusion criteria - 1. Individuals who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or 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 foods related to the test product

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

8. 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 in another study during this study

9. Individuals who may undergo treatment involving bleeding (including surgery or tooth extraction) during this study or within two weeks after the end of consumption

10. 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 11 Month 13 Day Date of IRB - 2024 Year 11 Month 13 Day Anticipated trial start date - 2024 Year 12 Month 02 Day Last follow-up date - 2025 Year 02 Month 06 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064363

Disclaimer: Curated by HT Syndication.