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

February 23, 2026 updated by: Kuan-Pin, National Science and Technology Council, Taiwan

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
    • Taichung
      • Taichung, Taichung, Taiwan, 404
        • Recruiting
        • Mind Body Interface Research Center (MBI Lab & Care)
        • Contact:
          • Kuan-Pin Su, MD, PhD
          • Phone Number: 14128 +886 (04) 2205-2121
          • Email: cobol@cmu.edu.tw

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Eicosapentaenoic Acid (EPA)
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)
25 participants are assigned
Other Names:
  • Eicosapentaenoic Acid
Placebo Comparator: Placebo
Sample size (n=25). Four capsules of Placebo will be administered at a dosage equal to two grams/day
Dietary supplement: Placebo
25 participants are assigned

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline
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.
Weeks 0, 2, 4, 8, and 12.
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.
Weeks 0, 2, 4, 8, and 12.
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.
Baseline and Endpoint

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Weeks 0, 2, 4, 8, and 12.
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.
Weeks 0, 2, 4, 8, and 12.
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
Weeks 0, 2, 4, 8, 12
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.
Weeks 0, 2, 4, 8, and 12.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Science and Technology Council, Taiwan

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ministry of Science and Technology, Taiwan
Fondation FondaMental
Fondation pour la Recherche Médicale (FRM)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 5, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 23, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 27, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 23, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CMUH109-REC3-045(AR-4)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Medical Conditions

Drug Interventions

Conditions

Rare Diseases

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Dietary Supplements

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Locations

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