Obesity
Conditions
Keywords
oxylipins, obesity, fish oil, omega 3 fatty acids, inflammation, Body Mass Index, omega 3 fatty acid supplementation
Brief 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. 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.
Interventions
DIETARY_SUPPLEMENTSPM 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).
Sponsors
University of North Carolina, Chapel Hill
Metagenics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Plasma Levels of Monohydroxylated n-3 PUFA Derivatives (14-HDHA, 17-HDHA, 18-HEPE) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Burnout Score | Baseline (Day 0) and End of Treatment (Week 12 ± 2-4 days) | 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. |
| Change in Life Satisfaction Score | Baseline (Day 0) and End of Treatment (Week 12 ± 2-4 days) | 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. |
| Change in Sleep Quality Score | Baseline (Day 0) and End of Treatment (Week 12 ± 2-4 days) | 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. |
Countries
United States
Contacts
CONTACTRafia Virk, MS
CONTACTSaame R Shaikh, PhD
PRINCIPAL_INVESTIGATORSaame Shaikh, PhD
University of North Carolina, Chapel Hill
Outcome results
None listed