EPICO: (Study for the Pro-resolution of Chronic Inflammation in Obesity. Original Acronym From Spanish)

NCT05068557 | Unknown DMC

• 1 other identifier: CI03221
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity; Chronic Inflammation

Keywords

PUFA omega 3; Obesity; Low-grade chronic inflammation; Specialized-proresolving mediators; Inflammation resolution

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

Intervention group

ACTIVE COMPARATOR

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).

Control group

PLACEBO COMPARATOR

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).

Interventions

Dietary plan along with fish oil capsules (3 capsules daily. Containing EPA+DHA: 1.8 g). DIETARY_SUPPLEMENT

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

Intervention group

Dietary plan along with chia/linseed oil capsules (3 capsules daily. Containing ALA 1.6 g). DIETARY_SUPPLEMENT

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

Control group

Eligibility Criteria

• Age: 25 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Guadalajara: lead

Study Sites (1)

University of Guadalajara (CUCS)

Guadalajara, Jalisco, 44340, Mexico

RECRUITING

Related Publications (4)

• 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. doi: 10.1080/08860220601184092.

  PMID: 17497447 BACKGROUND

• 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.

  PMID: 27531277 BACKGROUND

• 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.

  PMID: 31829100 BACKGROUND

• 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.

  PMID: 31492430 BACKGROUND

MeSH Terms

Conditions

Obesity

Interventions

Fish Oils

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Oils; Lipids

Central Study Contacts

Erika Martinez-Lopez, PhD

CONTACT

+523310585200; erikamtz@yahoo.com.mx

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Both type of capsules were deposited in equally labeled flaks under sterile conditions. Every flask was identified and tagged with a specific number by an associate researcher who is not involved in the recruitment, attention, or follow-up of the enrolled subjects. Finally, block randomization was the selected technique for this purpose.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: Double-blind randomized parallel clinical trial

Study Record Dates

• First Submitted: September 22, 2021
• First Posted: October 6, 2021
• Study Start: September 24, 2021
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: October 6, 2021

Record last verified: 2021-10

Locations

ME (1)