Status:
COMPLETED
Bioavailability of SPMs in Obese Humans
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
Metagenics, Inc.
North Carolina Translational and Clinical Sciences Institute
Conditions:
Obesity Adult Onset
Eligibility:
All Genders
50-65 years
Phase:
NA
Brief Summary
Research Question: Does 4 weeks of supplementation with 'SPM Active' lead to a statistically significant increase in plasma SPM concentration for obese human subjects? Primary Aim 1: To compare plasma...
Detailed Description
Purpose: Specialized pro-resolving mediators (SPMs) are a superfamily of lipid metabolites, predominantly derived from the n-3 polyunsaturated fatty acids (PUFAs) eicosapentaenoic (EPA) and docosahexa...
Eligibility Criteria
Inclusion
- 24 (n=12 male + 12 female) obese (BMI 30-40 kg/m\^2) subjects with age 50-65 years who are euglycemic and pre-diabetic (i.e. fasting glucose 70-125 mg/dL or HbA1c of 5.7-6.4%).
- Only post-menopausal females will be recruited in the female cohort to reduce the confounding effects of estrogen on lipid metabolism during supplementation.
Exclusion
- Those with fasting glucose values \> 126 mg/dL or known type 2 diabetes
- Females who are pre-menopausal, pregnant, planning to become pregnant, breastfeeding or lactating
- Subjects consuming n-3 PUFA supplements in the last 3 months prior to enrollment, high consumption of fatty fish (\>2 servings per week), and subjects with active autoimmune disease, liver disease, coagulopathy, hypothyroidism, known allergy to fish or shellfish, inability to give informed consent, or taking anticoagulants (e.g. warfarin and direct-acting anticoagulants), those taking estrogen or testosterone, and anyone taking daily aspirin, NSAIDs, or active asthma medications.
- Subjects receiving immunomodulatory or immunosuppressant therapy (corticosteroids or monoclonal antibodies) in the 4 weeks prior to study enrollment, and subjects with known active malignancy or undergoing treatment for malignancy will be excluded.
- Subjects who test positive for COVID-19 or have tested positive in the past will be excluded. Those who report COVID-19 or flu-like symptoms will be excluded, as well as those that fail to pass COVID-19 screening at baseline.
Key Trial Info
Start Date :
February 4 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 18 2021
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04701138
Start Date
February 4 2021
End Date
June 18 2021
Last Update
June 15 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
UNC Chapel Hill Family Medicine Center
Chapel Hill, North Carolina, United States, 27514