A Study to Verify the Sleep-improving Effects of the Test Food Consumption (NCT06907537) | Clinical Trial Compass
CompletedNot Applicable
A Study to Verify the Sleep-improving Effects of the Test Food Consumption
Japan44 participantsStarted 2025-04-03
Plain-language 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?
Participants will be given the following tasks:
* Take 4 capsules daily containing plasmalogens for 12 weeks.
* Answer the questionnaire on sleepiness1 when they wake up.
* Answer the questionnaire on daytime sleepiness2. Researchers will compare plasmalogens and placebo groups to see if plasmalogens reduce sleepiness upon waking.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Japanese
✓. Men or women
✓. Adults
✓. Healthy individuals
✓. Individuals whose Zc score of "sleepiness on rising" is relatively low at screening
Exclusion criteria
✕. 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
What they're measuring
1
The measured value of Zc score of "sleepiness on rising" in the OSA sleep inventory MA version (OSA-MA) after the 12-week intervention