A verification study to evaluate the safety of long-term consumption of the test food

UMIN ID: UMIN000056217

Registered date:20/11/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Healthy Japanese
• Date of first enrollment: 2024/11/20
• Target sample size: 20
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Duration: 12 weeks Test food: Food containing plasmalogen Administration: Take five capsules per day in the morning. *If you forget to take the test food, take it as soon as you remember. Daily dose should be taken within the day and not carried over to the next day.
Duration: 12 weeks Test food: Food not containing plasmalogen Administration: Take five capsules per day in the morning. *If you forget to take the test food, take it as soon as you remember. Daily dose should be taken within the day and not carried over to the next day.

Outcome(s)

• Primary Outcome: 1. Individuals who experienced adverse events
• Secondary Outcome: 1. Individuals whose values of blood test and urinalysis are outside the reference range after intervention despite within the reference range at screening (before intervention; Scr) <Exploratory outcomes> 1. The measured values of blood plasmalogen levels at 6 and 12 weeks after intervention (6w and 12w), and changes of them from Scr 2. Items in the St. Mary's Hospital Sleep Questionnaire (SMH) at 6w and 12w

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: Individuals who 1. are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction 2. have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. 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. 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. have habits of consuming foods or using devices to improve sleep 6. have irregular sleeping habits due to lifestyle such as night shifts 7. 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. have nocturia two times or more 9. 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. are taking "Foods for Specified Health Uses" or "Foods with Functional Claims" 11. are taking medications (including herbal medicines) or supplements 12. are allergic to medicines or foods related to the test product 13. are pregnant, lactating, or planning to become pregnant during this study 14. 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. are judged as ineligible to participate in this study by the physician

Related Information

• Primary Sponsor: ORTHOMEDICO Inc.
• Secondary Sponsor: Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic
• Source(s) of Monetary Support: AOBA KASEI CO., LTD.