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This is a 12-week, randomized, double-blind, placebo-controlled study to evaluate the effects of scallop-derived plasmalogen on brain fatigue, body weight and changes in blood plasmalogen in obese subjects aged 20-75 years old.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | Two 0.5 mg plasmalogen capsules per day |
|
| Placebo Group | Placebo Comparator | Two placebo capsules containing no plasmalogen per day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plasmalogen | Dietary Supplement | Treatment group takes two 0.5 mg plasmalogen capsules per day for 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Profile of Mood States 2nd Edition (POMS 2) | Psychological rating scale to assess transient feelings and mood | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in body weight | 12 weeks | |
| Change in waist diameter | 12 weeks | |
| Change in blood levels of plasmalogen |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Takehiko Fujino | BOOCS Clinic Fukuoka | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BOOCS Clinic Fukuoka | Fukuoka | 8120025 | Japan |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D010955 | Plasmalogens |
| ID | Term |
|---|---|
| D010742 | Phospholipid Ethers |
| D020404 | Glycerophospholipids |
| D010712 | Phosphatidic Acids |
| D005994 | Glycerophosphates |
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| Placebo | Dietary Supplement | Placebo Group takes two placebo capsules per day for 12 weeks. |
|
| 12 weeks |
| Change in Athens Insomnia Scale (AIS) | Self-assessment psychometric tool to quantify sleep difficulty | 12 weeks |
| Changes in adiponectin, leptin, IRI, GA, and high sensitive quantitation of C-reactive protein | 12 weeks |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010743 |
| Phospholipids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |