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| ID | Type | Description | Link |
|---|---|---|---|
| UMIN000057422 | Registry Identifier | UMIN-CTR |
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| Name | Class |
|---|---|
| AOBA KASEI CO., LTD. | UNKNOWN |
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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:
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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 four capsules per day in the morning. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | After the 12-week intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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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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| ID | Term |
|---|---|
| D005502 | Food |
| D010955 | Plasmalogens |
| ID | Term |
|---|---|
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
| D010742 | Phospholipid Ethers |
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| Food without plasmalogen |
| Dietary Supplement |
Take four capsules per day in the morning. |
|
| 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. | 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. | After the 6 and12-week intervention |
| Shinagawa-ku |
| Tokyo |
| 141-0022 |
| Japan |
| D020404 | Glycerophospholipids |
| D010712 | Phosphatidic Acids |
| D005994 | Glycerophosphates |
| D010743 | Phospholipids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |