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

Effects of 12-week n-3 PUFA Treatment (EPA) on Depressive Symptoms in Overweight/Obese Depressed Subjects With Low n-3 PUFA Status: Relationship With Systemic Inflammation

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07439744

Enrollment

Registered

2026-02-27

Start date

2025-03-01

Completion date

2027-12-01

Last updated

2026-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

MDD, Obese Adults

Brief summary

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.

Interventions

DIETARY_SUPPLEMENTEicosapentaenoic acid (omega-3 fatty acid)

25 participants are assigned

DIETARY_SUPPLEMENTPlacebo

25 participants are assigned

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Intervention model description

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.

Eligibility

Sex/Gender

ALL

Age

18 Years to 54 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Depression Diagnosis	Baseline	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 Severity	Weeks 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.
Concentration of Omega-3 Profile in Blood	Baseline and Endpoint	The level of Omega-3 will be assessed by Gas Chromatography based on the retention time.

Secondary

Measure	Time frame	Description
Stress Measurement	Weeks 0, 2, 4, 8, and 12.	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.
Food Frequency Assessment	Weeks 0, 2, 4, 8, and 12.	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.
Pleasure Measurement	Weeks 0, 2, 4, 8, 12	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
Fatigue Measurement	Weeks 0, 2, 4, 8, and 12.	Fatigue will be measured by the Multidimensional Fatigue Inventory (MFI). A total score of 60 or higher is considered indicative of clinically significant fatigue.

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026