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NCT Number: NCT07439744

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

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.

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Key information

Conditions

Obese Adults MDD

Age range

18 year–54 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mind Body Interface Research Center (MBI Lab & Care)

Taichung, 404, Taiwan

Location status: Recruiting

Location contact

Kuan-Pin Su, MD, PhD

CONTACT

[email protected]

+886 (04) 2205-2121 ext. 14128

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Eicosapentaenoic acid (omega-3 fatty acid)

Dietary Supplement

25 participants are assigned

Other names: Eicosapentaenoic Acid

Placebo

Dietary Supplement

25 participants are assigned

Primary outcomes

  1. Depression Diagnosis

    Time frame: 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.

  2. Depression Severity

    Time frame: 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.

  3. Depression Severity

    Time frame: Weeks 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.

  4. Concentration of Omega-3 Profile in Blood

    Time frame: Baseline and Endpoint

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

Secondary outcomes

  1. Stress Measurement

    Time frame: 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.

  2. Food Frequency Assessment

    Time frame: 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.

  3. Pleasure Measurement

    Time frame: 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

  4. Fatigue Measurement

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

National Science and Technology Council, Taiwan

Other Gov

Collaborators

  • Fondation FondaMental
  • Fondation pour la Recherche Médicale
  • Ministry of Science and Technology, Taiwan

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Feb 27, 2026
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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