Omega‑3 metabolite increase after SPM Active® supplementation in adults with obesity
Official title: Concentration of n-3 PUFA Monohydroxylated Derivatives in Adults With Obesity After Supplementation With "SPM Active®".
Run by University of North Carolina, Chapel Hill · NCT06991296 · Data updated 2026-11-12
This test will see if taking 2 g/day of SPM Active® for 12 weeks raises specific omega‑3 derivatives and improves burnout, life satisfaction, and sleep in adults aged 45–60 with obesity.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 45 Years to 60 Years |
| Sex | All |
| Enrollment | 33 (estimated) |
| Sponsor | University of North Carolina, Chapel Hill Academic / other |
| Locations | 1 site (Kannapolis, North Carolina) |
| Status | Recruiting |
| Started | June 2, 2025 |
| Main results expected | December 2026 |
| Study ends | December 2026 |
| Registry record updated | February 17, 2026 |
| Trial ID | NCT06991296 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults 45–60 years old with BMI 30–40 kg/m^2 who are not taking omega‑3 supplements, do not have diabetes or active autoimmune/liver disease, and can attend in-person visits at UNC Kannapolis.
✕Probably not a fit
Those with diagnosed type 1 or type 2 diabetes, active autoimmune disease, current malignancy, pregnancy, or regular use of excluded medications (e.g., anticoagulants, daily NSAIDs) may not benefit and are excluded.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study enrolls 33 adults aged 45–60 with BMI 30–40 kg/m^2 to take 2 g/day of SPM Active® (two soft-gel capsules) for 12 weeks. Fasting blood samples will be collected before and after the intervention to measure plasma levels of 14‑HDHA, 17‑HDHA, and 18‑HEPE. Participants will complete validated surveys on burnout, life satisfaction, and sleep quality at baseline and at study end. The trial is conducted at the UNC Nutrition Research Institute in Kannapolis, NC and excludes people with diabetes, active autoimmune or liver disease, recent high fish intake, or certain medication use.
Why it matters
Potential benefit: If successful, supplementation could raise anti-inflammatory omega‑3 derivatives and potentially improve measures of burnout, life satisfaction, and sleep in adults with obesity.
How similar studies have gone: Prior trials have shown omega‑3 supplements can increase SPM-related metabolites and reduce inflammatory markers, but translating these biochemical changes into consistent improvements in burnout, life satisfaction, or sleep remains unproven.
Who can join: the full rules
Show full inclusion / exclusion criteria
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 it's running
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UNC Nutrition Research Institute
Kannapolis, North Carolina, United States Recruiting
Study contacts
- Principal investigator: Saame Shaikh, PhD — University of North Carolina, Chapel Hill
- Study coordinator: Saame R Shaikh, PhD
- Email: shaikhsa@email.unc.edu
- Phone: 317-409-9565
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.