Clinical trial

NUTRIMOOD-Inflammation and Depressive Comorbidity in Obesity: Modulation by Omega-3 Polyunsaturated Fatty Acids Status

Recruiting now · Not applicable · 1 countries · Registry ID NCT07439744

Recruiting nowNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 54 Years

SexAll

Healthy volunteersNot accepted

ConditionObese Adults, MDD

Full registry criteria

Inclusion Criteria: * Major depressive disorder. * Antidepressant drug-free. Exclusion Criteria: * Schizophrenia * Mania * Anxiety disorders (except for social phobia and generalized anxiety that are often comorbid with MDD) * Obsessive-compulsive disorder * Post-traumatic stress disorder * Alcohol or drug abuse/dependence (except for nicotine) * Active suicidal ideation * Serious medical/neurological conditions, especially requiring corticosteroid/non-steroidal anti-inflammatory or immunosuppressive therapies or chronic thyroid hormone replacement

Treatments and study arms

Eicosapentaenoic acid (omega-3 fatty acid)

Dietary Supplement

25 participants are assigned

Placebo

Dietary Supplement

25 participants are assigned

Primary outcomes

Depression DiagnosisBaseline

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.

Depression SeverityWeeks 0, 2, 4, 8, and 12.

Depression Severity is assessed by utilizing the 17-item Hamilton Depression Rating Scale (HDRS). A score of ≥ 18 shows a significant level of depression.

Depression SeverityWeeks 0, 2, 4, 8, and 12.

Depression Severity is assessed by utilizing the Montgomery-Åsberg Depression Rating Scale (MADRS). A score of ≥ 20 shows a significant level of depression.

Concentration of Omega-3 Profile in BloodBaseline and Endpoint

The level of Omega-3 will be assessed by Gas Chromatography based on the retention time.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Mind Body Interface Research Center (MBI Lab & Care)🇹🇼 Taichung, Taichung, Taiwan

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Kuan-Pin Su, MD, PhDContact

Email · Call +886 (04) 2205-2121