RecruitingNot ApplicableNCT06991296

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®".

Sponsor

University of North Carolina, Chapel Hill

Enrollment

33 participants

Start Date

Jun 2, 2025

Study Type

INTERVENTIONAL

Conditions

Obesity

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

Min Age: 45 YearsMax Age: 60 Years

Inclusion Criteria3

adults, ages 45-60 years
Body mass index (BMI) between 30 and 40 kg/m\^2
Any race or ethnicity

Exclusion Criteria11

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.

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Interventions

DIETARY_SUPPLEMENTSPM Active®

Participants will take two SPM Active® soft-gel capsules orally each day (total 2 g/day of specialized pro-resolving mediators) for 12 weeks (± 2-4 days). Capsules are provided by Metagenics and contain monohydroxylated n-3 PUFA derivatives (14-HDHA, 17-HDHA, 18-HEPE).