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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
50
25 participants are assigned
25 participants are assigned
Mind Body Interface Research Center (MBI Lab & Care)
Taichung, Taichung, Taiwan
RECRUITINGDepression 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and Endpoint
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.
Time frame: Weeks 0, 2, 4, 8, and 12.
Food Frequency Assessment
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.
Time frame: 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
Time frame: 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.
Time frame: Weeks 0, 2, 4, 8, and 12.
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