Concentration of n-3 PUFA Monohydroxylated Derivatives in Adults With Obesity After n-3 PUFA Supplementation.
Recruiting · NCT06991296 · Interventional (participants receive a specific treatment) · Lead sponsor: University of North Carolina, Chapel Hill
View the official record on ClinicalTrials.gov →Interventions studied
What this trial 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. 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.
Who can take part
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 is running
1 location listed across 1 US state.
- UNC Nutrition Research Institute - Kannapolis, North Carolina, United States