Status:
COMPLETED
A Study to Verify the Sleep-improving Effects of the Test Food Consumption
Lead Sponsor:
Orthomedico Inc.
Collaborating Sponsors:
AOBA KASEI CO., LTD.
Conditions:
Healthy Japanese
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The goal of this clinical trial is to test in Japanese adults who feel sleepy when they wake up. The question it aims to answer are: •Does taking plasmalogens reduce sleepiness upon waking? Particip...
Eligibility Criteria
Inclusion
- Japanese
- Men or women
- Adults
- Healthy individuals
- Individuals whose Zc score of "sleepiness on rising" is relatively low at screening
Exclusion
- Individuals who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction
- Individuals who have a pacemaker or an implantable cardioverter defibrillator (ICD)
- 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
- 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
- Individuals who have habits of consuming foods or using devices to improve sleep
- Individuals who have irregular sleeping habits due to lifestyle such as night shifts
- 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
- Individuals who have nocturia two times or more
- 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)}
- Individuals who are taking "Foods for Specified Health Uses" or "Foods with Functional Claims"
- Individuals who are taking medications (including herbal medicines) or supplements
- Individuals who are allergic to medicines or foods related to the test product, or have a gelatin allergy or sea squirt-induced asthma
- Individuals who are pregnant, lactating, or planning to become pregnant during this study
- 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
- Individuals who are judged as ineligible to participate in this study by the physician
Key Trial Info
Start Date :
April 3 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2025
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT06907537
Start Date
April 3 2025
End Date
December 15 2025
Last Update
December 22 2025
Active Locations (2)
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1
Nerima Medical Association Minami-machi Clinic
Nerima-ku, Tokyo, Japan, 176-0002
2
Medical Corporation Seishinkai, Takara Clinic
Shinagawa-ku, Tokyo, Japan, 141-0022