Healthy JapaneseNCT06715475
A Verification Study to Evaluate the Safety of Long-term Consumption of the Test Food
A study testing Food containing plasmalogen and Food not containing plasmalogen in people with Healthy Japanese, run by Orthomedico Inc. at 2 sites in Japan.
Trial summary
This clinical study aims to verify the safety of consumption of plasmalogen-containing food for 12 weeks in healthy Japanese. The study will also exploratory assess blood plasmalogen levels and the effects of plasmalogen-containing food on sleep. 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 not containing plasmalogen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 2 sitesJapan
- Study dates
- 2 Dec 2024to 23 Apr 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
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 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
- Individuals who 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
- 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
- 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 Verification Study to Evaluate the Safety of Long-term Consumption of the Test Food: a Randomized, Placebo-controlled, Double-blind, Parallel-group Comparison Study
This clinical study aims to verify the safety of consumption of plasmalogen-containing food for 12 weeks in healthy Japanese. The study will also exploratory assess blood plasmalogen levels and the effects of plasmalogen-containing food on sleep.
Read the detailed description
In this study, the investigators will confirm the safety of consumption of plasmalogen-containing food for 12 weeks in healthy Japanese. The investigators will also exploratory assess blood plasmalogen levels and the effect of plasmalogen-containing food on sleep conditions. The groups to be compared are plasmalogen-containing food and a placebo (plasmalogen-free food).
- Conditions
- Healthy Japanese
- Being tested
- Food containing plasmalogen, Food not containing plasmalogen
- Keywords
- Plasmalogen, Safety, 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 five capsules per day in the morning.
Food not containing plasmalogenDietary supplement
Take five 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 not containing plasmalogen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of individuals who experienced adverse events
An adverse event is defined as the "development of a new abnormality" or "worsening" in physical signs, symptoms, etc. that is clinically meaningful to the study participant during the study period, and the investigator will evaluate the relationship between the adverse event and the test product.
Measured: Intervention period (up to 12 weeks)
Secondary outcomes (4)
Number of individuals whose values of blood test and urinalysis are outside the reference range after intervention despite within the reference range at Baseline (before intervention)
Count the number of individuals whose values of blood test items (white blood cell count, red blood cell count, hemoglobin level, hematocrit value, platelet count, aspartate transaminase, alanine transaminase, γ-glutamyltransferase, total bilirubin, total protein, urea nitrogen, creatinine, uric acid, sodium, potassium, chloride, serum amylase, total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, triglycerides, glucose, and hemoglobin A1c levels) and urinalysis items (urinary protein, glucose, pH, and occult blood) are outside the reference range after intervention (Week 6 and Week 12) despite within the reference range at Baseline.
Measured: Week 6 and Week 12
The measured values of blood plasmalogen levels at Week 6 and Week 12
This is one of the exploratory assessment items. Approximately 3 mL of venous blood will be collected from each study participant, and this sample will be analyzed.
Measured: Week 6 and Week 12
The changes from baseline of blood plasmalogen levels at Week 6 and Week 12
This is one of the exploratory assessment items. Approximately 3 mL of venous blood will be collected from each study participant, and this sample will be analyzed.
Measured: Baseline, Week 6, and Week 12
Each questionnaire item in the St. Mary's Hospital Sleep Questionnaire (SMH) at Week 6 and Week 12
These are one of the exploratory assessment items. The SMH is a self-administered tool to evaluate sleep over the past 24 hours. It includes questions with various response formats, such as yes/no answers, open-ended responses requiring specific time and time-of-day entries, and multiple-choice items with four or more options. Responses to the questions are reviewed individually.
Measured: Week 6 and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2024
- Study start2 Dec 2024
- Primary completion23 Apr 2025 (estimated)
- Study completion23 Apr 2025 (estimated)
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
- 24 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
- NCT06715475
- Sponsor's protocol ID
- 04400-0006-06
- Status last verified
- Mar 2025
- First submitted
- 22 Nov 2024
- Last updated
- 1 Apr 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 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Verification Study to Evaluate the Safety of Long-term Consumption of the Test Food: a Randomized, Placebo-controlled, Double-blind, Parallel-group Comparison Study
- ClinicalTrials.gov ID
- NCT06715475
- Acronym / sponsor ID
- 04400-0006-06
- Conditions
- Healthy Japanese
- Keywords
- Plasmalogen, Safety, Sleep condition
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Orthomedico Inc.University, hospital or other
- Collaborators
- AOBA KASEI CO., LTD.
- Study start
- 2 Dec 2024 (actual)
- Primary completion
- 23 Apr 2025 (estimated)
- Study completion
- 23 Apr 2025 (estimated)
- First posted
- 4 Dec 2024 (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.
This clinical study aims to verify the safety of consumption of plasmalogen-containing food for 12 weeks in healthy Japanese. The study will also exploratory assess blood plasmalogen levels and the effects of plasmalogen-containing food on sleep.
Detailed description
In this study, the investigators will confirm the safety of consumption of plasmalogen-containing food for 12 weeks in healthy Japanese. The investigators will also exploratory assess blood plasmalogen levels and the effect of plasmalogen-containing food on sleep conditions. The groups to be compared are plasmalogen-containing food and a placebo (plasmalogen-free food).
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 not containing 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 (4 listed)
- Japanese
- Men or women
- Adults
- Healthy individuals
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 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
- Individuals who 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
- 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 five capsules per day in the morning. | Dietary supplement | Plasmalogen |
| Food not containing plasmalogenTake five capsules per day in the morning. | Dietary supplement | Placebo |
Primary outcome
Number of individuals who experienced adverse events
Time frame: Intervention period (up to 12 weeks)
An adverse event is defined as the "development of a new abnormality" or "worsening" in physical signs, symptoms, etc. that is clinically meaningful to the study participant during the study period, and the investigator will evaluate the relationship between the adverse event and the test product.
4 secondary outcomes
Number of individuals whose values of blood test and urinalysis are outside the reference range after intervention despite within the reference range at Baseline (before intervention)
Time frame: Week 6 and Week 12
The measured values of blood plasmalogen levels at Week 6 and Week 12
Time frame: Week 6 and Week 12
The changes from baseline of blood plasmalogen levels at Week 6 and Week 12
Time frame: Baseline, Week 6, and Week 12
Each questionnaire item in the St. Mary's Hospital Sleep Questionnaire (SMH) at Week 6 and Week 12
Time frame: Week 6 and Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
- Individual participant dataSharing planned: No. Data sharing will be discussed among the research affiliates after the study is completed.
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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 not containing 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 4 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: under way, not looking for participants, as of the sponsor's last update on 1 Apr 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?
This study is still under way. Results are not available in the source record yet.
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?
Number of individuals who experienced adverse events (time frame: Intervention period (up to 12 weeks)). 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 1 Apr 2025.