RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-06-02
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06991296

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:45 Years to 60 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male adults, ages 45-60 years
  2. * Body mass index (BMI) between 30 and 40 kg/m\^2
  3. * Any race or ethnicity
  1. * Age \< 45 years or \> 60 years
  2. * Biologically female sex
  3. * BMI \< 30 kg/m\^2 or \> 40 kg/m\^2
  4. * Diagnosed type 1 or type 2 diabetes
  5. * Active autoimmune disease, liver disease, coagulopathy, or hypothyroidism
  6. * Known allergy to fish or shellfish
  7. * Current use of any of the following medications: asthma controller therapies, anticoagulants, estrogen or testosterone, daily aspirin or NSAIDs.
  8. * Inability to give informed consent
  9. * Receiving immunomodulatory or immunosuppressant therapy
  10. * Known active malignancy or undergoing treatment for malignancy
  11. * Use of n-3 PUFA supplements or high consumption of fatty fish (\> 2 servings/week) within 3 months prior to enrollment.

Contacts and Locations

Study Contact

Saame R Shaikh, PhD
CONTACT
317-409-9565
shaikhsa@email.unc.edu
Rafia Virk, MS
CONTACT
7036269517
drvirk@email.unc.edu

Principal Investigator

Saame Shaikh, PhD
PRINCIPAL_INVESTIGATOR
University of North Carolina, Chapel Hill

Study Locations (Sites)

UNC Nutrition Research Institute
Kannapolis, North Carolina, 28081
United States

Collaborators and Investigators

Sponsor: University of North Carolina, Chapel Hill

  • Saame Shaikh, PhD, PRINCIPAL_INVESTIGATOR, University of North Carolina, Chapel Hill

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-02
Study Completion Date2025-12

Study Record Updates

Study Start Date2025-06-02
Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Obesity