NCT06991296

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®".

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 33 (estimated)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: All
• Age: 45 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Purpose: This study aims to explore the effects of 'SPM Active®,' an omega-3 polyunsaturated fatty acid (n-3 PUFA) dietary supplement, on male adults with obesity. The supplement specifically targets the increase of monohydroxylated derivatives of n-3 PUFAs, which play a crucial role in reducing chronic, low-grade inflammation. The primary objective of the study is to determine whether administering SPM Active® at 2g/day for a longer duration (3 months) leads to higher levels of the monohydroxylated derivatives (14-HDHA, 17-HDHA, and 18-HEPE) in adults with obesity (BMI between 30 and 40 kg/m\^2, n=33). The secondary objective is to evaluate whether administration of SPM Active® improves the following outcomes: a) burnout, b) life satisfaction, and c) sleep quality. These outcomes will be assessed using validated surveys administered before and after the intervention. Participants: The study will include 33 healthy male and female participants of any ethnicity, aged 45-60 years, with a BMI of 30-40 kg/m\^2. Procedures: The intervention involves the administration of the dietary supplement 'SPM Active®' provided by Metagenics. All participants will take 2 soft gel capsules per day for 12 weeks, with a window of +/- 2-4 days. A 12-hour fasting blood sample will be collected from each participant before and after the intervention by a licensed phlebotomist at the UNC Nutrition Research Institute (NRI) at Kannapolis, NC. Additionally, participants will complete surveys at the start and end of the study.

Conditions

• Obesity

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	SPM 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).

Timeline

• Start date: 2025-06-02
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2025-05-27
• Last updated: 2026-02-17

Locations

1 site across 1 country: United States