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

ConditionsObese AdultsMDD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-54
SponsorNational Science and Technology Council, Taiwan

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Major depressive disorder.

Antidepressant drug-free.

Disqualifiers

Schizophrenia

Mania

Anxiety disorders (except for social phobia and generalized anxiety that are often comorbid with MDD)

Obsessive-compulsive disorder

Trial design

Design model

Parallel

Treatments tested in this trial

  • Eicosapentaenoic acid (omega-3 fatty acid)

    Dietary supplement

    25 participants are assigned

  • Placebo

    Dietary supplement

    25 participants are assigned

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Eicosapentaenoic Acid (EPA)Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline
2

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.

Time frame
Weeks 0, 2, 4, 8, and 12.
3

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.

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

Concentration of Omega-3 Profile in Blood

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

Time frame
Baseline and Endpoint

Secondary outcomes

1

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.

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

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.

Time frame
Weeks 0, 2, 4, 8, and 12.
3

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

Time frame
Weeks 0, 2, 4, 8, 12
4

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.

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

Other outcomes

Sponsors and contacts

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National Science and Technology Council, Taiwan

Lead sponsor

Ministry of Science and Technology, Taiwan

Sponsor institution

Fondation FondaMental

Collaborator

Fondation pour la Recherche Médicale (FRM)

Collaborator

Ministry of Science and Technology, Taiwan

Collaborator