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

NCT07439744 — Not applicable, Recruiting, 50 participants, National Science and Technology Council, Taiwan
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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

RegistryNCT07439744
StatusRecruiting
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: quadruple, treatment
Enrollment50 (Estimated)
SponsorNational Science and Technology Council, Taiwan (Other gov); collaborators: Fondation FondaMental, Fondation pour la Recherche Médicale, Ministry of Science and Technology, Taiwan
ConditionsObese Adults, MDD
InterventionsEicosapentaenoic acid (omega-3 fatty acid), Placebo (Dietary supplement)
Datesstart 2025-03-01, primary completion 2027-03-01 (estimated), completion 2027-12-01 (estimated), first posted 2026-02-27, last updated 2026-02-27
Locations1 site in Taiwan

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-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.

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+Arms and interventions

ArmTypeInterventionsDescription
Eicosapentaenoic Acid (EPA)ExperimentalDietary Supplement: Eicosapentaenoic acid (omega-3 fatty acid)Sample size (n=25). Four capsules of EPA will be administered at a dosage equal to two grams/day
PlaceboPlacebo comparatorDietary Supplement: PlaceboSample size (n=25). Four capsules of Placebo will be administered at a dosage equal to two grams/day
  • Eicosapentaenoic acid (omega-3 fatty acid) (Dietary supplement), also known as Eicosapentaenoic Acid: 25 participants are assigned
  • Placebo (Dietary supplement): 25 participants are assigned

+Outcome measures

Primary outcomes

  • 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.
  • Depression Severity [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.
  • 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 outcomes

  • 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.

+Eligibility

Sex: All, ages: 18 Years to 54 Years

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

+Locations (1)

FacilityCityCountryStatus
Mind Body Interface Research Center (MBI Lab & Care)Taichung, TaichungTaiwanRecruiting

My Notes