SPM Active® for Obesity

Overseen By Rafia Virk, MS

Age: 18 - 65

Sex: Any

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if daily SPM Active® supplements can improve well-being in adults with obesity by increasing certain omega-3 fatty acids in the body. The researchers will assess improvements in life satisfaction, burnout, and sleep quality. Participants will take two soft-gel capsules daily for 12 weeks and complete surveys about their feelings and sleep. The trial seeks adults aged 45-60 with a BMI between 30 and 40, who do not have diabetes or certain other health conditions. As an unphased trial, this study offers participants the chance to contribute to valuable research that could enhance well-being for many.

Will I have to stop taking my current medications?

Yes, you will need to stop taking certain medications, including asthma controller therapies, anticoagulants, estrogen or testosterone, daily aspirin, or NSAIDs, to participate in this trial.

What prior data suggests that SPM Active® is safe for adults with obesity?

Research has shown that SPM Active® is generally safe for use. This dietary supplement meets safety standards set by regulators. In previous studies, adults with obesity took 2 grams per day of a similar SPM supplement for four weeks without major safety issues. Participants tolerated the supplement well, and no serious side effects emerged. However, while early results appear promising, further research is necessary to fully confirm its long-term safety and effectiveness. ^{1 2 3 4 5}

Why are researchers excited about this trial?

SPM Active® is unique because it uses specialized pro-resolving mediators (SPMs), which are derived from omega-3 fatty acids, to address obesity. Unlike other treatments that might focus on suppressing appetite or blocking fat absorption, SPM Active® aims to resolve inflammation, a process that can be linked to obesity. Researchers are excited about this approach because targeting inflammation could potentially lead to improved overall metabolic health and offer a novel way to manage obesity.

What evidence suggests that SPM Active® might be an effective treatment for obesity?

Research has shown that SPM Active® might improve quality of life by boosting certain omega-3 compounds in the blood. These compounds, such as 17-HDHA and 18-HEPE, may help reduce inflammation and enhance overall well-being. Early evidence suggests that SPM Active® can increase life satisfaction, reduce burnout, and improve sleep quality. One study found that the supplement was well-absorbed in people with obesity, indicating its potential effectiveness. However, while the results are encouraging, more clinical trials are needed to confirm these benefits in humans. ^{3 4 5 6 7}

Who Is on the Research Team?

Saame Shaikh, PhD

Principal Investigator

University of North Carolina, Chapel Hill

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06991296

Concentration of n-3 PUFA Monohydroxylated Derivatives ...

The secondary objective is to evaluate whether administration of SPM Active® improves the following outcomes: a) burnout, b) life satisfaction, and c) sleep ...

2.

translational-medicine.biomedcentral.com

translational-medicine.biomedcentral.com/articles/10.1186/s12967-020-02569-5

Early evidence of efficacy for orally administered SPM ...

We conclude that oral supplementation with a fractionated marine lipid concentration standardized to 17-HDHA and 18-HEPE may improve quality of life.

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8496879/

Polyunsaturated fatty acids, specialized pro-resolving ...

In obese mice, SPM levels were generally higher in female mice than males. In a human study, females were found to have higher levels of SPMs relative to male ...

4.

metagenicsinstitute.com

metagenicsinstitute.com/articles/spm-obesity-clinical-trial-study/

Specialized Pro-Resolving Mediators Supplementation in ...

This study demonstrates that not only was this particular blend well-absorbed by obese patients, but also important SPM compounds that may provide far-reaching ...

5.

sciencedirect.com

sciencedirect.com/science/article/pii/S1756464624004419

Pro-resolving metabolites: Future of the fish oil supplements

While preclinical studies have shown promising results, more extensive clinical trials are needed to confirm the efficacy and safety of SPMs in human subjects.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9258560/

Enriched Marine Oil Supplement Increases Specific ...

SPM bioavailability has not been effectively established in adults with obesity who are taking marine oil supplements. This population is of interest as obesity ...

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07038252

The Effect of Oral SPM Supplementation on INflammation ...

It is used to investigate its effect on vascular function and inflammation in patients with obesity-related hypertension. The product is over-the-counter and ...