Omega‑3 metabolite increase after SPM Active® supplementation in adults with obesity
Concentration of n-3 PUFA Monohydroxylated Derivatives in Adults With Obesity After Supplementation With "SPM Active®".
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 33 (estimated) |
| Ages | 45 Years to 60 Years |
| Sex | All |
| Sponsor | University of North Carolina, Chapel Hill Academic / other |
| Locations | 1 site (Kannapolis, North Carolina) |
| Trial ID | NCT06991296 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Kannapolis, North Carolina
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.