NCT06991296 · University of North Carolina, Chapel Hill
Concentration of n-3 PUFA Monohydroxylated Derivatives in Adults With Obesity After n-3 PUFA Supplementation.
What this study is about
The goal of this clinical trial is to learn if daily supplementation with SPM Active® can increase omega 3 polyunsaturated fatty acid derivatives and improve well-being in adults with obesity.
View original scientific description
The goal of this clinical trial is to learn if daily supplementation with SPM Active® can increase omega 3 polyunsaturated fatty acid derivatives and improve well-being in adults with obesity. The main questions it aims to answer are: Does 2 g/day of SPM Active® for 12 weeks increase plasma levels of 14-hydroxydocosahexaenoic (HDHA), 17-HDHA, and 18-hydroxy eicosapentaenoic acid (HEPE)? Does 2 g/day of SPM Active® for 12 weeks improve self-reported burnout, life satisfaction, and sleep quality? Participants will: Take two SPM Active® soft-gel capsules daily for 12 weeks (±2-4 days). Provide 12-hour fasting blood samples before and after the intervention. Complete validated surveys on burnout, life satisfaction, and sleep quality at baseline and study end.
Interventions
DIETARY_SUPPLEMENT
SPM Active®
Participants will take two SPM Active® soft-gel capsules orally each day (total 2 g/day of specialized pro-resolving mediators) for 12 weeks (± 2-4 days). Capsules are provided by Metagenics and contain monohydroxylated n-3 PUFA derivatives (14-HDHA, 17-HDHA, 18-HEPE).
Primary outcome measures
Change in Plasma Levels of Monohydroxylated n-3 PUFA Derivatives (14-HDHA, 17-HDHA, 18-HEPE)
Time frame: Baseline (Day 0) and End of Treatment (Week 12 ± 2-4 days)
Mean change from baseline in fasting plasma concentrations of 14-HDHA, 17-HDHA, and 18-HEPE, as quantified by liquid chromatography-mass spectrometry.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- adults, ages 45-60 years
- Body mass index (BMI) between 30 and 40 kg/m\^2
- Any race or ethnicity
Exclusion criteria
- Age \< 45 years or \> 60 years
- pregnant or breastfeeding women
- BMI \< 30 kg/m\^2 or \> 40 kg/m\^2
- Diagnosed type 1 or type 2 diabetes
- Active autoimmune disease, liver disease, coagulopathy, or hypothyroidism
- Known allergy to fish or shellfish
- Current use of any of the following medications: asthma controller therapies, anticoagulants, estrogen or testosterone, daily aspirin or NSAIDs.
- Inability to give informed consent
- Receiving immunomodulatory or immunosuppressant therapy
- Known active malignancy or undergoing treatment for malignancy
- Use of n-3 PUFA supplements or high consumption of fatty fish (\> 2 servings/week) within 3 months prior to enrollment.
Where
- Kannapolis, North Carolina
Collaborators
Metagenics, Inc.
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 17, 2026 · Source of record for eligibility and locations