An interventional study of Dietary plan along with fish oil capsules (3 capsules daily. Containing EPA+DHA: 1.8 g). and Dietary plan along with chia/linseed oil capsules (3 capsules daily. Containing ALA 1.6 g). in Obesity and Chronic Inflammation, sponsored by University of Guadalajara. Status unknown at 1 site in Mexico. Open to participants aged 25 Years to 59 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-10-06.
Sponsored by University of Guadalajara · Not applicable, Interventional, and Treatment
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.
A total of 80 subjetcs will be invited to be enrolled in a nutrigenomics/nutrigenetics study approaching the properties of a dietary plan (mild calorie restriction and adjusted at an omega-6/omega-3 fatty acids ratio of 4:1, and supplemented with fish oil rich in EPA and DHA or placebo).
This double blind, randomized, parallel clinical trial will consist in a 12-week intervention with recurrent visits every 4 weeks. Subjects will be required to follow the dietary plan provided in a recipee book produced and edited by our research group along with a capsule in every major meal (breakfast, lunch, and dinner) for 12 weeks. In every visit, all subects will undergo a body composition analysis as well as blood tests that include: total cell count, glucose and lipid homeostasis, serum inflammatory markers, DNA extraction for genetic tests (SNPs involved in inflammation), isolation and ex vivo stimulation of neutrophils, determination of and isolation of PBMCs for further analysis of gene expression and protein abundance.
This study proposes three distinct but closely related approaches for reaching a further understanding of the actions of EPA and DHA intake:
All these approaches will have in common the correlation with serum inflammatory markers (TNF alpha, MCP1, IL-6, and IL-10).
Once the project is finished, the research strategies for new studies will be improved. In the same way, the application of the knowledge generated in it will be encouraged towards the health care of patients with obesity who could attend our service on future occasions. Finally, we would disseminate the knowledge generated in our institutional community, which would increase the impact of the project.
In summary, the impact is divided into the following points:
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
This study's planned enrollment of 80 is close to the median of 78 across 4,878 interventional studies indexed under Obesity.
Browse Obesity studies →University of Guadalajara is the lead sponsor of 94 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Dietary plan with a mild calorie restriction and adjusted in PUFA omega-3/omega-6 ratio (4:1) along with fish oil (3 capsules daily. Containing EPA+DHA: 1.8 g). (n=40)
Dietary Supplement: Dietary plan along with fish oil capsules (3 capsules daily. Containing EPA+DHA: 1.8 g).
Dietary plan with a mild calorie restriction and adjusted in PUFA omega-3/omega-6 ratio (4:1) along with chia/linseed oil (3 capsules daily. Containing ALA 1.6 g). (n=40)
Dietary Supplement: Dietary plan along with chia/linseed oil capsules (3 capsules daily. Containing ALA 1.6 g).
Subects within the Intervention group will be provided with a dietary plan along with fish oil capsules. Subjects will be asked to consume three capsules per day. Every capsule contains: EPA+DHA: 1.8 g.
Also known as: Dietary intervention along with fish oil
Subects within the Intervention group will be provided with a dietary plan along with fish oil capsules. Subjects will be asked to consume three capsules per day. Every capsule contains: ALA 1.6 g).
Also known as: Placebo
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).
Time frame: 12 weeks
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).
Time frame: 12 weeks
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)
Time frame: 12 weeks
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University of Guadalajara