Obesity Clinical Trial
— EPICOOfficial title:
Dietary Intervention Supplemented With PUFA Omega-3 Fatty Acids on the Pro-resolving Capacity in Subjects With Obesity.
Omega-3 fatty acids, especially EPA and DHA have long been acknowledged for their capacity to counteract inflammatory responses in the human body. Understanding the impact of the dietary intake of these fatty acids along with others (such as ARA) involved in inflammation is essential for prevention and treatment of chronic non-communicable diseases as it is obesity and its comorbidities. The role that the EPA and DHA play in the inflammatory processes can be understood by studying the capacity of certain immune cells and their genetic background to respond under the constant exposure to an adjusted diet in omega-6/omega-3 fatty acids in individuals with obesity.
Status | Recruiting |
Enrollment | 80 |
Est. completion date | December 2021 |
Est. primary completion date | December 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 25 Years to 59 Years |
Eligibility | Inclusion Criteria: - 25-59 years of age, both sexes - Subjects who agree to participate in the study and all signed informed consent - BMI 30 kg/m2 - 39.9 kg/m2 - Waist circumference >88 cm for females; >102 cm for males Exclusion Criteria: - Currently consuming any of the following drugs: NSAIDS, anticoagulants, hypoglycemic, oR hypolipemic drugs - Diagnosed autoimmune diseases - Diagnosed cancer - Pregnancy and breastfeeding - Allergy to chia, linseed or fish oil - Subjects who wish to abandon the study |
Country | Name | City | State |
---|---|---|---|
Mexico | University of Guadalajara (CUCS) | Guadalajara | Jalisco |
Lead Sponsor | Collaborator |
---|---|
University of Guadalajara |
Mexico,
Barden A, Shinde S, Tsai IJ, Croft KD, Beilin LJ, Puddey IB, Mori TA. Effect of weight loss on neutrophil resolvins in the metabolic syndrome. Prostaglandins Leukot Essent Fatty Acids. 2019 Sep;148:25-29. doi: 10.1016/j.plefa.2019.07.001. Epub 2019 Jul 3. — View Citation
Polus A, Zapala B, Razny U, Gielicz A, Kiec-Wilk B, Malczewska-Malec M, Sanak M, Childs CE, Calder PC, Dembinska-Kiec A. Omega-3 fatty acid supplementation influences the whole blood transcriptome in women with obesity, associated with pro-resolving lipid mediator production. Biochim Biophys Acta. 2016 Nov;1861(11):1746-1755. doi: 10.1016/j.bbalip.2016.08.005. Epub 2016 Aug 12. — View Citation
Rasic-Milutinovic Z, Perunicic G, Pljesa S, Gluvic Z, Sobajic S, Djuric I, Ristic D. Effects of N-3 PUFAs supplementation on insulin resistance and inflammatory biomarkers in hemodialysis patients. Ren Fail. 2007;29(3):321-9. — View Citation
Souza PR, Marques RM, Gomez EA, Colas RA, De Matteis R, Zak A, Patel M, Collier DJ, Dalli J. Enriched Marine Oil Supplements Increase Peripheral Blood Specialized Pro-Resolving Mediators Concentrations and Reprogram Host Immune Responses: A Randomized Double-Blind Placebo-Controlled Study. Circ Res. 2020 Jan 3;126(1):75-90. doi: 10.1161/CIRCRESAHA.119.315506. Epub 2019 Dec 12. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Resolvin E1 and D1 secretion under stimulation conditions (ex vivo). | Stimulation of neutrophils from subjects who underwent a dietary plan (mild calorie restriction along with an omega-6/omega-3 adjusted ratio and supplemented with fish oil or placebo) and their correlation with inflammatory markers (serum TNF alpha, IL-6, MCP1, and IL-10). The major markers of change are resolvin E1 and resolvin D1 (RvE1 and RvD1). | 12 weeks | |
Primary | Genetic analysis of Single Nucleotide Polymorphism (SNPs) involved in the synthesis of specialized pro-resolving mediators (SPMs). | Subjects who underwent a dietary plan (mild calorie restriction along with an omega-6/omega-3 fatty acids adjusted ratio and supplemented with fish oil or placebo) will be genotyped based on inflammatory genetic variants: CYP4F3 (rs1805042), PTGS2 (rs5275, rs20417, and rs689466) y ALOX15 (rs11568131) and their correlation with the (ex vivo) secretion of Resolvin E1 and D1 and with inflammatory markers (serum TNF alpha, IL-6, MCP1, and IL-10). | 12 weeks | |
Primary | Analysis of the activation of FFAR4 in PBMCs | Analysis through immunoprecipitation and immunoblotting to determine the activation of FFAR4 in PBMCs and their correlation with inflammatory markers (serum TNF alpha, IL-6, MCP1, and IL-10). Subjects who underwent a dietary plan (mild calorie restriction along with an omega-6/omega-3 fatty acids adjusted ratio and supplemented with fish oil or placebo) | 12 weeks |
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