Actively Recruiting

Phase Not Applicable
Age: 45Years - 60Years
All Genders
NCT06991296

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

Led by University of North Carolina, Chapel Hill · Updated on 2026-02-17

33

Participants Needed

1

Research Sites

78 weeks

Total Duration

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Sponsors

U

University of North Carolina, Chapel Hill

Lead Sponsor

M

Metagenics, Inc.

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 45Years - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 45 to 60 years
  • Body mass index (BMI) between 30 and 40 kg/m2
  • Any race or ethnicity
Not Eligible

You will not qualify if you...

  • Age under 45 years or over 60 years
  • Pregnant or breastfeeding women
  • BMI less than 30 kg/m2 or greater than 40 kg/m2
  • Diagnosed type 1 or type 2 diabetes
  • Active autoimmune disease, liver disease, coagulopathy, or hypothyroidism
  • Known allergy to fish or shellfish
  • Current use of 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 (more than 2 servings per week) within 3 months prior to enrollment

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

UNC Nutrition Research Institute

Kannapolis, North Carolina, United States, 28081

Actively Recruiting

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Research Team

S

Saame R Shaikh, PhD

CONTACT

R

Rafia Virk, MS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

1

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