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

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 Overview

• Status: Recruiting
• Conditions: MDD; Obese Adults
• Intervention / Treatment: Dietary supplement: Eicosapentaenoic acid (omega-3 fatty acid); Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taichung
    • Taichung, Taichung, Taiwan, 404
      • Recruiting
      • Mind Body Interface Research Center (MBI Lab & Care)
      • Contact: Kuan-Pin Su, MD, PhD; Phone Number: 14128 +886 (04) 2205-2121; Email: cobol@cmu.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Eicosapentaenoic Acid (EPA); Sample size (n=25). Four capsules of EPA will be administered at a dosage equal to two grams/day	Dietary supplement: Eicosapentaenoic acid (omega-3 fatty acid); 25 participants are assigned; Other Names: Eicosapentaenoic Acid
Placebo Comparator: Placebo; Sample size (n=25). Four capsules of Placebo will be administered at a dosage equal to two grams/day	Dietary supplement: Placebo; 25 participants are assigned

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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.

Collaborators and Investigators

• Sponsor: National Science and Technology Council, Taiwan
• Collaborators: Ministry of Science and Technology, Taiwan; Fondation FondaMental; Fondation pour la Recherche Médicale (FRM)

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: February 5, 2026
• First Submitted That Met QC Criteria: February 23, 2026
• First Posted (Actual): February 27, 2026

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 23, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fatty Acids; Lipids; Eicosanoids; Fatty Acids, Unsaturated; Oils; Dietary Fats; Fats; Dietary Fats, Unsaturated; Fish Oils; Eicosapentaenoic Acid; Fatty Acids, Omega-3
• Other Study ID Numbers: CMUH109-REC3-045(AR-4)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No