NCT06991296Recruiting
Concentration of n-3 PUFA Monohydroxylated Derivatives in Adults With Obesity After n-3 PUFA Supplementation.
Concentration of n-3 PUFA Monohydroxylated Derivatives in Adults With Obesity After Supplementation With "SPM Active®".
Source: ClinicalTrials.gov · Last updated 17 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 33 (estimated)
- First submitted
- 19 May 2025
- Start date
- 2 Jun 2025
- Primary completion date
- Dec 2026
- Lead sponsor
- University of North Carolina, Chapel Hill
- Diseases
- Obesity
- NCT number
- NCT06991296
What you commit to
- Study type: Interventional
- Planned participants: 33
- From 2 Jun 2025 to the primary completion date, Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current use of any of the following medications: asthma controller therapies, anticoagulants, estrogen or testosterone, daily aspirin or NSAIDs.
- Receiving immunomodulatory or immunosuppressant therapy
- Use of n-3 PUFA supplements or high consumption of fatty fish (\> 2 servings/week) within 3 months prior to enrollment.
Other illness
- Diagnosed type 1 or type 2 diabetes
- Active autoimmune disease, liver disease, coagulopathy, or hypothyroidism
- Known allergy to fish or shellfish
- Known active malignancy or undergoing treatment for malignancy
Age
- Age \< 45 years or \> 60 years
Other
- pregnant or breastfeeding women
- BMI \< 30 kg/m\^2 or \> 40 kg/m\^2
- Inability to give informed consent
Who the study is looking for
- adults, ages 45-60 years
- Body mass index (BMI) between 30 and 40 kg/m\^2
- Any race or ethnicity
Age in the registry: 45 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UNC Nutrition Research Institute Coordinator of this site? Confirm its status | Kannapolis | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.