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

Concentration of n-3 PUFA Monohydroxylated Derivatives in Adults With Obesity After Supplementation With "SPM Active®".

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
45 Years to 60 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 12 weeks
  • Procedures mentioned: Pills, Blood draws, Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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)?"
  • "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."
  • "These outcomes will be assessed using validated surveys administered before and after the intervention."
  • "All participants will take 2 soft gel capsules per day for 12 weeks, with a window of +/- 2-4 days."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether taking 2 grams of SPM Active® daily for 12 weeks raises blood levels of certain substances made from omega-3 fats. It also tests whether the supplement improves burnout, life satisfaction, and sleep quality. It is for adults ages 45–60 with obesity.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 45–60.
  • Body mass index (BMI), a measure of weight compared with height, between 30 and 40.
  • People of any race or ethnicity can join.

Who can't join

  • Under age 45 or over age 60, or a BMI below 30 or above 40.
  • Pregnant or breastfeeding.
  • Type 1 or type 2 diabetes.
  • An active disease where the immune system attacks the body, liver disease, a blood-clotting disorder, or an underactive thyroid.
  • A known allergy to fish or shellfish.
  • Use of asthma control medicines, blood thinners, estrogen, testosterone, daily aspirin or other NSAIDs (anti-inflammatory pain medicines), or treatments that change or weaken the immune system.
  • Unable to give informed consent (agree to join after understanding the study), or having active cancer or receiving cancer treatment.
  • Use of omega-3 supplements or eating more than 2 servings of fatty fish per week within the 3 months before joining.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (1)

NC