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| Name | Class |
|---|---|
| AOBA KASEI CO., LTD. | UNKNOWN |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Plasmalogen | Active Comparator | Take 1 mg/day of plasmalogen |
|
| Placebo | Placebo Comparator | Take 0 mg/day of plasmalogen |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Food containing plasmalogen | Dietary Supplement | Take five capsules per day in the morning. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Intervention period (up to 12 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tsuyoshi Takara, MD | Medical Corporation Seishinkai, Takara Clinic | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nerima Medical Association Minami-machi Clinic | Nerima-ku | Tokyo | 176-0002 | Japan | ||
| Medical Corporation Seishinkai, Takara Clinic |
Data sharing will be discussed among the research affiliates after the study is completed.
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| Food not containing plasmalogen |
| Dietary Supplement |
Take five capsules per day in the morning. |
|
| 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. | 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. | 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. | Week 6 and Week 12 |
| Shinagawa-ku |
| Tokyo |
| 141-0022 |
| Japan |