ObesityNCT06991296
Concentration of n-3 PUFA Monohydroxylated Derivatives in Adults With Obesity After n-3 PUFA Supplementation.
A study testing SPM Active® in people with Obesity, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 45 to 60 years
- Conditions the study is for
- Obesity
- What is being tested?
- SPM Active®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jun 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- adults, ages 45-60 years
- Body mass index (BMI) between 30 and 40 kg/m^2
- Any race or ethnicity
Who cannot join
- 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
Show all 11Show fewer
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UNC Nutrition Research Institute
Kannapolis, North Carolina, 28081
Saroja Voruganti, PHD, 704-250-5009, saroja@ad.unc.edu
About this study
Official title: Concentration of n-3 PUFA Monohydroxylated Derivatives in Adults With Obesity After Supplementation With "SPM Active®".
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)?
Read more
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.
Read the detailed 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.
- Conditions
- Obesity
- Being tested
- SPM Active®
- Keywords
- oxylipins, obesity, fish oil, omega 3 fatty acids, inflammation, Body Mass Index, omega 3 fatty acid supplementation
- Medical subject headings
- Obesity, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPM Active®Dietary supplement
Participants will take two SPM Active® soft-gel capsules orally each day (total 2 g/day of specialized pro-resolving mediators) for 12 weeks (± 2-4 days). Capsules are provided by Metagenics and contain monohydroxylated n-3 PUFA derivatives (14-HDHA, 17-HDHA, 18-HEPE).
| Study group | Role | What they receive |
|---|---|---|
| SPM Active® Supplementation | Experimental | 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. Receives: Dietary Supplement: SPM Active® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Plasma Levels of Monohydroxylated n-3 PUFA Derivatives (14-HDHA, 17-HDHA, 18-HEPE)
Mean change from baseline in fasting plasma concentrations of 14-HDHA, 17-HDHA, and 18-HEPE, as quantified by liquid chromatography-mass spectrometry.
Measured: Baseline (Day 0) and End of Treatment (Week 12 ± 2-4 days)
Secondary outcomes (3)
Change in Burnout Score
The assessment of this survey is validated in a systematic review titled, "Maslach Burnout Inventory-General Survey: A Systematic Review and Meta-Analysis of Measurement Properties." This survey is measured on a scale form 0-6 where 0 is never experiencing the stated type of burnout and 6 being experiencing burnout every day. It is divided into three subscale measurements on emotional exhaustion, cynicism, and professional efficacy. High levels of burnout are indicated by high scores in emotional exhaustion and cynicism, along with low scores in professional efficacy.
Measured: Baseline (Day 0) and End of Treatment (Week 12 ± 2-4 days)
Change in Life Satisfaction Score
The life satisfaction survey assesses global life satisfaction and its validity review is conducted by William Pavot and Ed Diener in "The satisfaction With Life Scale and the merging construct of life satisfaction." This survey is measured on a scale of 1-7 where 1 is strongly disagree and 7 is strongly agree. A low score indicates low life satisfaction, whereas a high score indicates a high level of life satisfaction.
Measured: Baseline (Day 0) and End of Treatment (Week 12 ± 2-4 days)
Change in Sleep Quality Score
The sleep quality survey is validated by University of Pittsburgh and is detailed in "The Pittsburgh sleep quality index: a new instrument for psychiatric practice and research." The sleep quality survey is converted to scores, where the scores range form 0-3 with a higher score being indicative of more sleep disturbances.
Measured: Baseline (Day 0) and End of Treatment (Week 12 ± 2-4 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2025
- Study start2 Jun 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Metagenics, Inc.
- Responsible party
- Sponsor
- Investigators
- Saame Shaikh, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06991296
- Sponsor's protocol ID
- 24-0328
- Status last verified
- Feb 2026
- First submitted
- 19 May 2025
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concentration of n-3 PUFA Monohydroxylated Derivatives in Adults With Obesity After Supplementation With "SPM Active®".
- ClinicalTrials.gov ID
- NCT06991296
- Acronym / sponsor ID
- 24-0328
- Conditions
- Obesity
- Keywords
- oxylipins, obesity, fish oil, omega 3 fatty acids, inflammation, Body Mass Index, omega 3 fatty acid supplementation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Metagenics, Inc.
- Study start
- 2 Jun 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 27 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SPM Active® Supplementation | Experimental | Dietary Supplement: SPM Active®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 may qualify
- Ages
- 45 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- adults, ages 45-60 years
- Body mass index (BMI) between 30 and 40 kg/m^2
- Any race or ethnicity
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SPM Active®Participants will take two SPM Active® soft-gel capsules orally each day (total 2 g/day of specialized pro-resolving mediators) for 12 weeks (± 2-4 days). Capsules are provided by Metagenics and contain monohydroxylated n-3 PUFA derivatives (14-HDHA, 17-HDHA, 18-HEPE). | Dietary supplement | SPM Active® Supplementation |
Primary outcome
Change in Plasma Levels of Monohydroxylated n-3 PUFA Derivatives (14-HDHA, 17-HDHA, 18-HEPE)
Time frame: Baseline (Day 0) and End of Treatment (Week 12 ± 2-4 days)
Mean change from baseline in fasting plasma concentrations of 14-HDHA, 17-HDHA, and 18-HEPE, as quantified by liquid chromatography-mass spectrometry.
3 secondary outcomes
Change in Burnout Score
Time frame: Baseline (Day 0) and End of Treatment (Week 12 ± 2-4 days)
Change in Life Satisfaction Score
Time frame: Baseline (Day 0) and End of Treatment (Week 12 ± 2-4 days)
Change in Sleep Quality Score
Time frame: Baseline (Day 0) and End of Treatment (Week 12 ± 2-4 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Individual participant dataSharing planned: Yes. Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Saame Shaikh, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SPM Active® in people with Obesity, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Saame R Shaikh, PhD (317-409-9565, shaikhsa@email.unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Plasma Levels of Monohydroxylated n-3 PUFA Derivatives (14-HDHA, 17-HDHA, 18-HEPE) (time frame: Baseline (Day 0) and End of Treatment (Week 12 ± 2-4 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.