RECRUITING

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

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.

Conditions

Obesity
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Related Conditions:

Obesity

Study Overview

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Study Details

Study overview

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.

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

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

Condition
Obesity
Intervention / Treatment

-

Contacts and Locations

Kannapolis

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

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

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

Ages Eligible for Study

45 Years to 60 Years

Sexes Eligible for Study

MALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of North Carolina, Chapel Hill,

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

Study Record Dates

2025-12