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

NCT07439744 | Recruiting DMC

• 1 other identifier: CMUH109-REC3-045(AR-4)
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Obese Adults; MDD

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Stress Measurement

  Weeks 0, 2, 4, 8, and 12.

• Food Frequency Assessment

  Weeks 0, 2, 4, 8, and 12.

• Pleasure Measurement

  Weeks 0, 2, 4, 8, 12

• Fatigue Measurement

  Weeks 0, 2, 4, 8, and 12.

Study Arms (2)

Eicosapentaenoic Acid (EPA)

EXPERIMENTAL

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)

Placebo

PLACEBO COMPARATOR

Sample size (n=25). Four capsules of Placebo will be administered at a dosage equal to two grams/day

Dietary Supplement: Placebo

Interventions

Eicosapentaenoic acid (omega-3 fatty acid) DIETARY_SUPPLEMENT

25 participants are assigned

Also known as: Eicosapentaenoic Acid

Eicosapentaenoic Acid (EPA)

Placebo DIETARY_SUPPLEMENT

25 participants are assigned

Placebo

Eligibility Criteria

• Age: 18 Years - 54 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Major depressive disorder.
• Antidepressant drug-free.

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Mind Body Interface Research Center (MBI Lab & Care)

Taichung, Taichung, 404, Taiwan

RECRUITING

MeSH Terms

Interventions

Eicosapentaenoic Acid; Fatty Acids, Omega-3

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: February 5, 2026
• First Posted: February 27, 2026
• Study Start: March 1, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)