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

NCT06991296 | Recruiting

• 1 other identifier: 24-0328
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change in Plasma Levels of Monohydroxylated n-3 PUFA Derivatives (14-HDHA, 17-HDHA, 18-HEPE)

  Mean change from baseline in fasting plasma concentrations of 14-HDHA, 17-HDHA, and 18-HEPE, as quantified by liquid chromatography-mass spectrometry.

  Baseline (Day 0) and End of Treatment (Week 12 ± 2-4 days)

Secondary Outcomes (3)

• Change in Burnout Score

  Baseline (Day 0) and End of Treatment (Week 12 ± 2-4 days)

• Change in Life Satisfaction Score

  Baseline (Day 0) and End of Treatment (Week 12 ± 2-4 days)

• Change in Sleep Quality Score

  Baseline (Day 0) and End of Treatment (Week 12 ± 2-4 days)

Study Arms (1)

SPM Active® Supplementation

EXPERIMENTAL

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.

Dietary Supplement: SPM Active®

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).

SPM Active® Supplementation

Eligibility Criteria

• Age: 45 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Metagenics, Inc.: collaborator

Study Sites (1)

UNC Nutrition Research Institute

Kannapolis, North Carolina, 28081, United States

RECRUITING

MeSH Terms

Conditions

Obesity; Inflammation

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• Saame Shaikh, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Saame R Shaikh, PhD

CONTACT

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

Rafia Virk, MS

CONTACT

7036269517; drvirk@email.unc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2025
• First Posted: May 27, 2025
• Study Start: June 2, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: They willl be shared beginning 9 to 36 months following publication of study. Anticipated: December 2025 to March 2028.

Locations

US (1)