A Study to Verify the Sleep-improving Effects of the Test Food Consumption

Launched by ORTHOMEDICO INC. · Mar 27, 2025

Keywords

ClinConnect Summary

This clinical trial is looking to see if a substance called plasmalogens can help reduce feelings of sleepiness when people wake up. The study involves healthy Japanese adults aged 65 to 74 who often feel drowsy in the morning. Participants will take four capsules containing plasmalogens every day for 12 weeks and answer questions about their sleepiness both when they wake up and throughout the day. Researchers will compare the results between those taking plasmalogens and those taking a placebo (a capsule with no active ingredients) to see if there is any difference in sleepiness levels.

To participate, individuals must be healthy Japanese adults who do not have certain medical conditions, such as heart disease or sleep disorders, and who do not use sleep aids or have irregular sleeping habits. Those who are pregnant, nursing, or have allergies related to the study product are also excluded. If you qualify and choose to participate, you can expect to take the capsules daily and complete questionnaires about your sleepiness, helping researchers understand whether plasmalogens can improve morning wakefulness.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Japanese
• • 2. Men or women
• • 3. Adults
• • 4. Healthy individuals
• • 5. Individuals whose Zc score of "sleepiness on rising" is relatively low at screening
• 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 of 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 of any of the following diseases: mental disorders (e.g., 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, or have a gelatin allergy or sea squirt-induced asthma
• • 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