NCT06991296 Concentration of n-3 PUFA Monohydroxylated Derivatives in Adults With Obesity After n-3 PUFA Supplementation.
| NCT ID | NCT06991296 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of North Carolina, Chapel Hill |
| Condition | Obesity |
| Study Type | INTERVENTIONAL |
| Enrollment | 33 participants |
| Start Date | 2025-06-02 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 33 participants in total. It began in 2025-06-02 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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.
Contact & Investigator
Saame Shaikh, PhD
PRINCIPAL INVESTIGATOR
University of North Carolina, Chapel Hill
Frequently Asked Questions
Who can join the NCT06991296 clinical trial?
This trial is open to participants of all sexes, aged 45 Years or older, up to 60 Years, studying Obesity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06991296 currently recruiting?
Yes, NCT06991296 is actively recruiting participants. Contact the research team at shaikhsa@email.unc.edu for enrollment information.
Where is the NCT06991296 trial being conducted?
This trial is being conducted at Kannapolis, United States.
Who is sponsoring the NCT06991296 clinical trial?
NCT06991296 is sponsored by University of North Carolina, Chapel Hill. The principal investigator is Saame Shaikh, PhD at University of North Carolina, Chapel Hill. The trial plans to enroll 33 participants.
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