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

University of North Carolina (UNC)

Status: Enrolling

Conditions: Obesity

Treatments: Dietary Supplement: SPM Active®

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06991296

24-0328

Details and patient eligibility

About

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 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.

Full 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 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 and female 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.

Enrollment: 33 estimated patients

Sex: All

Ages: 45 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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
• pregnant or breastfeeding women
• 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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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33 participants in 1 patient group

SPM Active® Supplementation

Experimental group

Description:

All participants will take two SPM Active® soft-gel capsules daily (total 2 g/day) for 12 weeks (± 2-4 days). Fasting blood samples will be drawn at baseline and at end-of-treatment to quantify 14-HDHA, 17-HDHA, and 18-HEPE levels. Validated surveys assessing burnout, life satisfaction, and sleep quality will be administered before and after the supplementation period.

Treatment:

Dietary Supplement: SPM Active®