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ACTIVE NOT RECRUITING

NCT06715475

A Verification Study to Evaluate the Safety of Long-term Consumption of the Test Food

Sponsor: Orthomedico Inc.

View on ClinicalTrials.gov

Summary

This clinical study aims to verify the safety of consumption of plasmalogen-containing food for 12 weeks in healthy Japanese. The study will also exploratory assess blood plasmalogen levels and the effects of plasmalogen-containing food on sleep.

Official title: A Verification Study to Evaluate the Safety of Long-term Consumption of the Test Food: a Randomized, Placebo-controlled, Double-blind, Parallel-group Comparison Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2024-12-02

Completion Date

2025-04-23

Last Updated

2025-04-01

Healthy Volunteers

Yes

Conditions

Healthy Japanese

Interventions

DIETARY_SUPPLEMENT

Food containing plasmalogen

Take five capsules per day in the morning.

DIETARY_SUPPLEMENT

Food not containing plasmalogen

Take five capsules per day in the morning.

Inclusion Criteria: 1. Japanese 2. Men or women 3. Adults 4. Healthy individuals 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 undergoing medical treatment or have a medical history for any of the following diseases: mental disorder (such as depression), sleep apnea syndrome, hypersomnia, narcolepsy, insomnia, or valvular heart disease 5. Individuals who have habits of consuming foods or using devices to improve sleep 6. Individuals who have irregular sleeping habits due to lifestyle such as night shifts 7. Individuals who fall under the following sleeping conditions: sleeping in the same room with two or more people, living with preschool-aged children, living with individuals who require nursing care, or having their sleep potentially disturbed by the influence of others 8. Individuals who have nocturia two times or more 9. Individuals who usually drink to excess (average of more than about 20 g/day as absolute alcohol intake) {500 mL: a medium bottle of beer or about 1.5 cans of canned chu-hi, 180 mL: 1 go of sake or about 1.5 glasses of wine, 90 mL: half-go with shochu, 60 mL: a glass of whiskey brandy (double)} 10. Individuals who are taking "Foods for Specified Health Uses" or "Foods with Functional Claims" 11. Individuals who are taking medications (including herbal medicines) or supplements 12. Individuals who are allergic to medicines or foods related to the test product 13. Individuals who are pregnant, lactating, or planning to become pregnant during this study 14. 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 15. Individuals who are judged as ineligible to participate in this study by the physician

Locations (2)

Nerima Medical Association Minami-machi Clinic

Nerima-ku, Tokyo, Japan

Medical Corporation Seishinkai, Takara Clinic

Shinagawa-ku, Tokyo, Japan