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Recruiting NCT07439744

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

No phase Interventional Obese Adults MDD

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Eicosapentaenoic acid (omega-3 fatty acid), Placebo.
Who it may be relevant to
Registry conditions: Obese Adults, MDD. Basic parameters: 18 years — 54 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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 supplement Eicosapentaenoic acid (omega-3 fatty acid)
    25 participants are assigned
  • Dietary supplement Placebo
    25 participants are assigned

Primary outcome measures

  • Depression Diagnosis [Time frame: Baseline]
  • Depression Severity [Time frame: Weeks 0, 2, 4, 8, and 12.]
  • Depression Severity [Time frame: Weeks 0, 2, 4, 8, and 12.]
  • Concentration of Omega-3 Profile in Blood [Time frame: Baseline and Endpoint]
Secondary outcome measures (4)
  • Stress Measurement [Time frame: Weeks 0, 2, 4, 8, and 12.]
  • Food Frequency Assessment [Time frame: Weeks 0, 2, 4, 8, and 12.]
  • Pleasure Measurement [Time frame: Weeks 0, 2, 4, 8, 12]
  • Fatigue Measurement [Time frame: Weeks 0, 2, 4, 8, and 12.]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Taiwan · 1 center
  • Mind Body Interface Research Center (MBI Lab & Care) — Taichung

Identifiers

NCT: NCT07439744 · CMUH109-REC3-045(AR-4)

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗