Concentration of n-3 PUFA Monohydroxylated Derivatives in Male Adults With Obesity After n-3 PUFA Supplementation.
Launched by UNIVERSITY OF NORTH CAROLINA, CHAPEL HILL · May 19, 2025
Trial Information
Current as of August 19, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at whether taking a daily supplement called SPM Active® can help improve certain health markers and overall well-being in men who are overweight or obese. Specifically, the researchers want to find out if taking 2 grams of this supplement every day for 12 weeks can increase levels of specific omega-3 fatty acids in the blood and also improve feelings of burnout, life satisfaction, and sleep quality.
To participate in this study, men aged 45 to 60 with a body mass index (BMI) between 30 and 40 may be eligible. Participants will take two soft-gel capsules of SPM Active® each day for three months. They will need to provide blood samples after fasting for 12 hours at the start and end of the study, and they will also fill out surveys about their feelings of burnout, life satisfaction, and sleep quality. It’s important to note that certain health conditions or medications may make someone ineligible to participate, so a thorough screening will take place.
Gender
MALE
Eligibility criteria
- Inclusion Criteria:
- • Male 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
- • Biologically female sex
- • 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.
About University Of North Carolina, Chapel Hill
The University of North Carolina at Chapel Hill (UNC) is a leading research institution renowned for its commitment to advancing health and science through innovative clinical trials. With a robust infrastructure that supports multidisciplinary collaboration, UNC conducts cutting-edge research across various fields, including medicine, public health, and biomedical sciences. The university is dedicated to improving patient care and health outcomes by translating its research findings into practical applications. UNC’s clinical trials are designed to evaluate new therapies, interventions, and technologies, ensuring that they meet the highest ethical and scientific standards while fostering a culture of inclusivity and community engagement.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Kannapolis, North Carolina, United States
Patients applied
Trial Officials
Saame Shaikh, PhD
Principal Investigator
University of North Carolina, Chapel Hill
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported