SPM Active® for Obesity

Overseen By Rafia Virk, MS

Age: 18 - 65

Sex: Male

Trial Phase: Academic

Sponsor: University of North Carolina, Chapel Hill

Must not be taking: Asthma controllers, Anticoagulants, Estrogen, Testosterone

Disqualifiers: Diabetes, Autoimmune, Liver, Malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 12 weeks

33 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Saame Shaikh, PhD

Principal Investigator

University of North Carolina, Chapel Hill

Eligibility Criteria

This trial is for male adults with obesity who are interested in testing whether a daily supplement, SPM Active®, can boost certain omega-3 fatty acid derivatives and enhance overall well-being. Participants will need to take the supplement for 12 weeks and provide blood samples while also completing surveys about their burnout, life satisfaction, and sleep quality.

Inclusion Criteria

I am a man between 45 and 60 years old.

Body mass index (BMI) between 30 and 40 kg/m^2

Any race or ethnicity

Exclusion Criteria

BMI < 30 kg/m^2 or > 40 kg/m^2

Known allergy to fish or shellfish

I am either younger than 45 or older than 60.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants take two SPM Active® soft-gel capsules daily for 12 weeks to assess changes in plasma levels of n-3 PUFA derivatives and improvements in burnout, life satisfaction, and sleep quality.

12 weeks

2 visits (in-person) for blood samples at baseline and end of treatment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• SPM Active®

Trial Overview The study tests if taking 2 grams of SPM Active® every day increases levels of specific omega-3 derivatives (14-HDHA, 17-HDHA, and HEPE) in the blood. It also examines whether this supplementation improves feelings of burnout, life contentment, and sleep over a period of three months.

Participant Groups

Group I: SPM Active® Supplementation Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

Metagenics, Inc.

Industry Sponsor

Trials

15

Recruited

1,400+