Concentration of n-3 PUFA Monohydroxylated Derivatives in Adults With Obesity After n-3 PUFA Supplementation.

Part of paid clinical trials in Kannapolis, North Carolina.

Sponsor
University of North Carolina, Chapel Hill
Study ID
NCT06991296
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
45 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • SPM Active® — DIETARY_SUPPLEMENT
    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).

Study Details

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.

Key Dates

Start date
Jun 2, 2025
Status verified
Feb 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
33 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: SPM Active® Supplementation
    All participants will take two SPM Active® soft-gel capsules daily (total 2 g/day) for 12 weeks (± 2-4 days). Fasting blood samples will be drawn at baseline and at end-of-treatment to quantify 14-HDHA, 17-HDHA, and 18-HEPE levels. Validated surveys assessing burnout, life satisfaction, and sleep quality will be administered before and after the supplementation period.

Primary Outcome Measure

Change in Plasma Levels of Monohydroxylated n-3 PUFA Derivatives (14-HDHA, 17-HDHA, 18-HEPE) [ Time Frame: Baseline (Day 0) and End of Treatment (Week 12 ± 2-4 days) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UNC Nutrition Research InstituteKannapolisNorth Carolina28081
Saroja Voruganti, PHD
[email protected]
704-250-5009

Find similar trials in Kannapolis, NC

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
UNC Nutrition Research Institute· Kannapolis, NC

Related Studies