Clinical trial NCT06991296: Concentration of n-3 PUFA Monohydroxylated Derivatives in Male Adults With Obesity After n-3 PUFA Supplementation.
Official title: Concentration of n-3 PUFA Monohydroxylated Derivatives in Male Adults With Obesity After Supplementation With "SPM Active®".
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Obesity
Keywords: oxylipins
obesity
fish oil
omega 3 fatty acids
inflammation
Body Mass Index
omega 3 fatty acid supplementation
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Metagenics, Inc.
First posted: 2025-05-27
Enrollment: 33
Sex: MALE
Minimum age (years): 45
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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 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.

Detailed description: Purpose: This study aims to explore the effects of 'SPM Active®,' an omega-3 polyunsaturated fatty acid (n-3 PUFA) dietary supplement, on male adults with obesity. The supplement specifically targets the increase of monohydroxylated derivatives of n-3 PUFAs, which play a crucial role in reducing chronic, low-grade inflammation. The primary objective of the study is to determine whether administering SPM Active® at 2g/day for a longer duration (3 months) leads to higher levels of the monohydroxylated derivatives (14-HDHA, 17-HDHA, and 18-HEPE) in male adults with obesity (BMI between 30 and 40 kg/m\^2, n=33). The secondary objective is to evaluate whether administration of SPM Active® improves the following outcomes: a) burnout, b) life satisfaction, and c) sleep quality. These outcomes will be assessed using validated surveys administered before and after the intervention.

Participants: The study will include 33 healthy male participants of any ethnicity, aged 45-60 years, with a BMI of 30-40 kg/m\^2.

Procedures: The intervention involves the administration of the dietary supplement 'SPM Active®' provided by Metagenics. All participants will take 2 soft gel capsules per day for 12 weeks, with a window of +/- 2-4 days. A 12-hour fasting blood sample will be collected from each participant before and after the intervention by a licensed phlebotomist at the UNC Nutrition Research Institute (NRI) at Kannapolis, NC. Additionally, participants will complete surveys at the start and end of the study.

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.

Primary outcomes:
measure: Change in Plasma Levels of Monohydroxylated n-3 PUFA Derivatives (14-HDHA, 17-HDHA, 18-HEPE)
timeFrame: Baseline (Day 0) and End of Treatment (Week 12 ± 2-4 days)
Secondary outcomes:
measure: Change in Burnout Score
timeFrame: Baseline (Day 0) and End of Treatment (Week 12 ± 2-4 days)
measure: Change in Life Satisfaction Score
timeFrame: Baseline (Day 0) and End of Treatment (Week 12 ± 2-4 days)
measure: Change in Sleep Quality Score
timeFrame: Baseline (Day 0) and End of Treatment (Week 12 ± 2-4 days)
Other outcomes:
Locations:
city: Kannapolis
country: United States
facility: UNC Nutrition Research Institute
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Saame Shaikh, PhD
role: PRINCIPAL_INVESTIGATOR
References: