Healthy JapaneseNCT06907537
A Study to Verify the Sleep-improving Effects of the Test Food Consumption
A study testing Food containing plasmalogen and Food without plasmalogen in people with Healthy Japanese, run by Orthomedico Inc. at 2 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Japanese
- What is being tested?
- Food containing plasmalogen and Food without plasmalogen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 2 sitesJapan
- Study dates
- 3 Apr 2025to 15 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Japanese
- Men or women
- Adults
- Healthy individuals
- Individuals whose Zc score of "sleepiness on rising" is relatively low at screening
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Japan2 sites
Nerima Medical Association Minami-machi Clinic
Nerima-ku, Tokyo, 176-0002
Medical Corporation Seishinkai, Takara Clinic
Shinagawa-ku, Tokyo, 141-0022
About this study
Official title: A Study to Verify the Sleep-improving Effects of the Test Food Consumption: a Randomized, Placebo-controlled, Double-blind, Parallel-group Comparison Study
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.
- Conditions
- Healthy Japanese
- Being tested
- Food containing plasmalogen, Food without plasmalogen
- Keywords
- Plasmalogen, Sleep condition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food containing plasmalogenDietary supplement
Take four capsules per day in the morning.
Food without plasmalogenDietary supplement
Take four capsules per day in the morning.
| Study group | Role | What they receive |
|---|---|---|
| Plasmalogen | Active comparator | Take 1 mg/day of plasmalogen Receives: Dietary Supplement: Food containing plasmalogen |
| Placebo | Placebo comparator | Take 0 mg/day of plasmalogen Receives: Dietary Supplement: Food without plasmalogen |
What is being measured
The primary outcome is the main question the study is designed to answer.
The measured value of Zc score of "sleepiness on rising" in the OSA sleep inventory MA version (OSA-MA) after the 12-week intervention
The OSA-MA is used to assess sleep quality. Individuals are asked to complete the questionnaire immediately after waking on the examination day and two days before the examination. The raw scores from each examination day will be converted to Zc scores, and the three-day mean, rounded to one decimal place, will be used as the measured value. "Sleepiness on rising" consists of four questions. Higher score indicates better outcome.
Measured: After the 12-week intervention
Secondary outcomes (3)
The measured value of Zc score of "sleepiness on rising" in the OSA-MA after the 6-week intervention
The OSA-MA is used to assess sleep quality. Individuals are asked to complete the questionnaire immediately after waking on the examination day and two days before the examination. The raw scores from each examination day will be converted to Zc scores, and the three-day mean, rounded to one decimal place, will be used as the measured value. "Sleepiness on rising" consists of four questions. Higher score indicates better outcome.
Measured: After the 6-week intervention
The measured values of Zc score of "initiation and maintenance of sleep," "frequent dreaming," "refreshing," and "sleep length" in the OSA-MA after the 6 and12-week intervention
The OSA-MA is used to assess sleep quality. Individuals are asked to complete the questionnaire immediately after waking on the examination day and two days before the examination. The raw scores from each examination day will be converted to Zc scores, and the three-day mean, rounded to one decimal place, will be used as the measured value. "Initiation and maintenance of sleep" consists of five questions, "frequent dreaming" consists of two questions, "refreshing" consists of three questions, and "sleep length" consists of two questions. Higher scores indicate better outcomes.
Measured: After the 6 and12-week intervention
The measured value of total score of the Athens Insomnia Scale (AIS) after the 6 and12-week intervention
The AIS is used to assess sleep-related issues over the past month. Individuals are asked to answer eight sleep-related questions by selecting one of four response options, indicating experiences they have had at least three times per week in the past month. Lower score indicates better outcome.
Measured: After the 6 and12-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2025
- Study start3 Apr 2025
- Primary completion15 Dec 2025
- Study completion15 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy JapaneseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orthomedico Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- AOBA KASEI CO., LTD.
- Responsible party
- Sponsor
- Investigators
- Tsuyoshi Takara, MD, Study chair, Medical Corporation Seishinkai, Takara Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06907537
- Sponsor's protocol ID
- 04400-0010-16
- Other IDs
- UMIN000057422
- Status last verified
- May 2025
- First submitted
- 27 Mar 2025
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data sharing will be discussed among the research affiliates after the study is completed.
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Verify the Sleep-improving Effects of the Test Food Consumption: a Randomized, Placebo-controlled, Double-blind, Parallel-group Comparison Study
- ClinicalTrials.gov ID
- NCT06907537
- Acronym / sponsor ID
- 04400-0010-16
- Conditions
- Healthy Japanese
- Keywords
- Plasmalogen, Sleep condition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Orthomedico Inc.University, hospital or other
- Collaborators
- AOBA KASEI CO., LTD.
- Study start
- 3 Apr 2025 (actual)
- Primary completion
- 15 Dec 2025 (actual)
- Study completion
- 15 Dec 2025 (actual)
- First posted
- 2 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Plasmalogen | Active comparator | Dietary Supplement: Food containing plasmalogenTake 1 mg/day of plasmalogen |
| Placebo | Placebo comparator | Dietary Supplement: Food without plasmalogenTake 0 mg/day of plasmalogen |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Japanese
- Men or women
- Adults
- Healthy individuals
- Individuals whose Zc score of "sleepiness on rising" is relatively low at screening
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Food containing plasmalogenTake four capsules per day in the morning. | Dietary supplement | Plasmalogen |
| Food without plasmalogenTake four capsules per day in the morning. | Dietary supplement | Placebo |
Primary outcome
The measured value of Zc score of "sleepiness on rising" in the OSA sleep inventory MA version (OSA-MA) after the 12-week intervention
Time frame: After the 12-week intervention
The OSA-MA is used to assess sleep quality. Individuals are asked to complete the questionnaire immediately after waking on the examination day and two days before the examination. The raw scores from each examination day will be converted to Zc scores, and the three-day mean, rounded to one decimal place, will be used as the measured value. "Sleepiness on rising" consists of four questions. Higher score indicates better outcome.
3 secondary outcomes
The measured value of Zc score of "sleepiness on rising" in the OSA-MA after the 6-week intervention
Time frame: After the 6-week intervention
The measured values of Zc score of "initiation and maintenance of sleep," "frequent dreaming," "refreshing," and "sleep length" in the OSA-MA after the 6 and12-week intervention
Time frame: After the 6 and12-week intervention
The measured value of total score of the Athens Insomnia Scale (AIS) after the 6 and12-week intervention
Time frame: After the 6 and12-week intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Individual participant dataSharing planned: No. Data sharing will be discussed among the research affiliates after the study is completed.
Related trials for Healthy Japanese
Not yet recruitingPhase 1
A Clinical Study to Assess the Safety, Tolerability and Pharmacokinetics of Orally Administered Cannabidiol Capsules (AVAT-121) and Epidyolex® in Healthy Adults
Focal Onset Seizure
RecruitingPhase 1
A Phase 1 Trial of AMG 691 in Healthy Chinese and Japanese Volunteers
Healthy Participants
RecruitingPhase 1
A Clinical Trial of MK-8644 in Healthy Participants and Participants With Psoriasis (MK-8644-001)
Psoriasis, Healthy
RecruitingPhase 1
A Study of LY5625575 in Healthy Participants and in Participants With Inflammation (Elevated C-Reactive Protein)
Healthy Volunteers, C-Reactive Protein
Not yet recruitingPhase 1
A Study of Single and Multiple Doses of LY5625573 in Healthy Participants, Including Japanese and Chinese Populations, and Participants With Inflammation (High C-Reactive Protein)
C-Reactive Protein
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tsuyoshi Takara, MD study chair
Medical Corporation Seishinkai, Takara Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Food containing plasmalogen and Food without plasmalogen in people with Healthy Japanese, run by Orthomedico Inc. at 2 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The measured value of Zc score of "sleepiness on rising" in the OSA sleep inventory MA version (OSA-MA) after the 12-week intervention (time frame: After the 12-week intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.