Concentration of n-3 PUFA Monohydroxylated Derivatives in Male Adults With Obesity After Supplementation With SPM Active®.

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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 male 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
Participation Requirements
Sex: Male
Minimum Age: 45
Maximum Age: 60
Healthy Volunteers: f
View:

• Male adults, ages 45-60 years

• Body mass index (BMI) between 30 and 40 kg/m\^2

• Any race or ethnicity

Locations
United States
North Carolina
UNC Nutrition Research Institute
RECRUITING
Kannapolis
Contact Information
Primary
Saame R Shaikh, PhD
shaikhsa@email.unc.edu
317-409-9565
Backup
Rafia Virk, MS
drvirk@email.unc.edu
7036269517
Time Frame
Start Date: 2025-06-02
Estimated Completion Date: 2025-12
Participants
Target number of participants: 33
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: University of North Carolina, Chapel Hill
Collaborators: Metagenics, Inc.

This content was sourced from clinicaltrials.gov