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| Name | Class |
|---|---|
| Fondation FondaMental | OTHER |
| Fondation pour la Recherche Médicale | OTHER |
| Ministry of Science and Technology, Taiwan | OTHER_GOV |
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A 12-week, randomized, placebo-controlled trial testing the efficacy of n-3 PUFA treatment (EPA, 2 g/day) in alleviating depressive symptoms in a subgroup of obese subjects with comorbid depression and low n-3 PUFA status (n-3 index < 8%) (81), from the Taiwanese cohort. Associations with PLA2/COX2 genotypes, lifestyle, nutritional profiles and gut microbiota will also be determined.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eicosapentaenoic Acid (EPA) | Experimental | Sample size (n=25). Four capsules of EPA will be administered at a dosage equal to two grams/day |
|
| Placebo | Placebo Comparator | Sample size (n=25). Four capsules of Placebo will be administered at a dosage equal to two grams/day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eicosapentaenoic acid (omega-3 fatty acid) | Dietary Supplement | 25 participants are assigned |
|
| Measure | Description | Time Frame |
|---|---|---|
| Depression Diagnosis | Patients are diagnosed with depression by utilizing the Mini-International Neuropsychiatric Interview (M.I.N.I.). The screening of emotional disturbances has shown that a total score of 4 or more. | Baseline |
| Depression Severity | Depression Severity is assessed by utilizing the 17-item Hamilton Depression Rating Scale (HDRS). A score of ≥ 18 shows a significant level of depression. | Weeks 0, 2, 4, 8, and 12. |
| Depression Severity | Depression Severity is assessed by utilizing the Montgomery-Åsberg Depression Rating Scale (MADRS). A score of ≥ 20 shows a significant level of depression. | Weeks 0, 2, 4, 8, and 12. |
| Concentration of Omega-3 Profile in Blood | The level of Omega-3 will be assessed by Gas Chromatography based on the retention time. | Baseline and Endpoint |
| Measure | Description | Time Frame |
|---|---|---|
| Stress Measurement | Stress level will be measured by utilizing the Perceived Stress Scale. A score of 26 is considered a reference point for high, potentially clinically significant stress. | Weeks 0, 2, 4, 8, and 12. |
| Food Frequency Assessment |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mind Body Interface Research Center (MBI Lab & Care) | Recruiting | Taichung | Taichung | 404 | Taiwan |
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| ID | Term |
|---|---|
| D015118 | Eicosapentaenoic Acid |
| D015525 | Fatty Acids, Omega-3 |
| ID | Term |
|---|---|
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
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After one week of placebo lead-in, obese patients with comorbid depression will be randomized to either EPA (2 g/day, 4 capsules) (n=25) or placebo (n=25) for 12 consecutive weeks.
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| Placebo | Dietary Supplement | 25 participants are assigned |
|
Food Frequency Assessment will be measured by using the Food Frequency Questionnaire (FFQ). Statistical thresholds used to identify implausible energy reports, categorize participants by intake levels (e.g., quartiles), or determine high/low risk.
| Weeks 0, 2, 4, 8, and 12. |
| Pleasure Measurement | Pleasure Measurement will be measured by the Snaith-Hamilton Pleasure Scale (SHPS). Score of 3 or more (with a range of 0-14) to indicate the presence of significant anhedonia | Weeks 0, 2, 4, 8, 12 |
| Fatigue Measurement | Fatigue will be measured by the Multidimensional Fatigue Inventory (MFI). A total score of 60 or higher is considered indicative of clinically significant fatigue. | Weeks 0, 2, 4, 8, and 12. |
| D015777 |
| Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |