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.
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
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.