Obese AdultsNCT07439744
NUTRIMOOD-Inflammation and Depressive Comorbidity in Obesity: Modulation by Omega-3 Polyunsaturated Fatty Acids Status
A study testing Eicosapentaenoic acid (omega-3 fatty acid) in people with Obese Adults and MDD, run by National Science and Technology Council, Taiwan at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 54 years
- Conditions the study is for
- Obese Adults, MDD
- What is being tested?
- Eicosapentaenoic acid (omega-3 fatty acid)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Mar 2025to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 54 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Major depressive disorder.
- Antidepressant drug-free.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Mind Body Interface Research Center (MBI Lab & Care)
Taichung, Taichung, 404
Kuan-Pin Su, MD, PhD, +886 (04) 2205-2121 ext. 14128, cobol@cmu.edu.tw
About this study
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
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.
- Conditions
- Obese Adults, MDD
- Being tested
- Eicosapentaenoic acid (omega-3 fatty acid), Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eicosapentaenoic acid (omega-3 fatty acid)Dietary supplement
Also called Eicosapentaenoic Acid
25 participants are assigned
PlaceboDietary supplement
25 participants are assigned
| Study group | Role | What they receive |
|---|---|---|
| Eicosapentaenoic Acid (EPA) | Experimental | Sample size (n=25). Four capsules of EPA will be administered at a dosage equal to two grams/day Receives: Dietary Supplement: Eicosapentaenoic acid (omega-3 fatty acid) |
| Placebo | Placebo comparator | Sample size (n=25). Four capsules of Placebo will be administered at a dosage equal to two grams/day Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
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.
Measured: Weeks 0, 2, 4, 8, and 12.
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.
Measured: Weeks 0, 2, 4, 8, and 12.
Concentration of Omega-3 Profile in Blood
The level of Omega-3 will be assessed by Gas Chromatography based on the retention time.
Measured: Baseline and Endpoint
Secondary outcomes (4)
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.
Measured: Weeks 0, 2, 4, 8, and 12.
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.
Measured: Weeks 0, 2, 4, 8, and 12.
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
Measured: Weeks 0, 2, 4, 8, 12
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.
Measured: Weeks 0, 2, 4, 8, and 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start1 Mar 2025
- Primary completionMar 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obese AdultsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- After one week of placebo lead-in, obese patients with comorbid depression will be randomized to either EPA (2 g/day, 4 capsules) (n=25) or placebo (n=25) for 12 consecutive weeks.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Science and Technology Council, Taiwan
- Sponsor type
- Other government
- Collaborators
- Fondation FondaMental, Fondation pour la Recherche Médicale, Ministry of Science and Technology, Taiwan
- Responsible party
- Principal investigator, Kuan-Pin, Ministry of Science and Technology, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07439744
- Sponsor's protocol ID
- CMUH109-REC3-045(AR-4)
- Status last verified
- Feb 2026
- First submitted
- 5 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07439744
- Acronym / sponsor ID
- CMUH109-REC3-045(AR-4)
- Conditions
- Obese Adults, MDD
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- National Science and Technology Council, TaiwanOther government
- Collaborators
- Fondation FondaMental, Fondation pour la Recherche Médicale, Ministry of Science and Technology, Taiwan
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- After one week of placebo lead-in, obese patients with comorbid depression will be randomized to either EPA (2 g/day, 4 capsules) (n=25) or placebo (n=25) for 12 consecutive weeks.
| Arm | Type | Receives |
|---|---|---|
| Eicosapentaenoic Acid (EPA) | Experimental | Dietary 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 |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboSample size (n=25). Four capsules of Placebo will be administered at a dosage equal to two grams/day |
Who may qualify
- Ages
- 18 to 54 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Major depressive disorder.
- Antidepressant drug-free.
Key exclusion criteria (8 listed)
- Schizophrenia
- Mania
- Anxiety disorders (except for social phobia and generalized anxiety that are often comorbid with MDD)
- Obsessive-compulsive disorder
- Post-traumatic stress disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eicosapentaenoic acid (omega-3 fatty acid)Also: Eicosapentaenoic Acid25 participants are assigned | Dietary supplement | Eicosapentaenoic Acid (EPA) |
| Placebo25 participants are assigned | Dietary supplement | Placebo |
Primary outcome
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.
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.
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.
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.
4 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eicosapentaenoic acid (omega-3 fatty acid) in people with Obese Adults and MDD, run by National Science and Technology Council, Taiwan at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression Diagnosis (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.