Recruiting

SPM Active®

Sponsor:

University of North Carolina, Chapel Hill

Code:

NCT06991296

Conditions

Obesity

Eligibility Criteria

Sex: All

Age: 45 - 60

Healthy Volunteers: Not accepted

Interventions

SPM Active®

Study Details

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.

Conditions

Obesity

Study ID

NCT06991296

Start date

Jun 2, 2025

Status verified date

Feb, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45 - 60

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

33 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

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.

Interventions

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).

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 and Locations

Central contacts

Saame R Shaikh, PhD

317-409-9565shaikhsa@email.unc.edu

Rafia Virk, MS

7036269517drvirk@email.unc.edu

Locations

UNC Nutrition Research Institute

Recruiting

Kannapolis, North Carolina, United States, 28081

Contacts

Saroja Voruganti, PHD

704-250-5009saroja@ad.unc.edu

More Information

Sponsor

University of North Carolina, Chapel Hill

Last update posted

Feb 17, 2026

Last verified

Feb, 2026

Keywords

  • oxylipins
  • obesity
  • fish oil
  • omega 3 fatty acids
  • inflammation
  • Body Mass Index
  • omega 3 fatty acid supplementation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of North Carolina, Chapel Hill on 2026-02-17.