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

Primary Purpose

Obesity, Chronic Inflammation

Status
Unknown status
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Dietary plan along with fish oil capsules (3 capsules daily. Containing EPA+DHA: 1.8 g).
Dietary plan along with chia/linseed oil capsules (3 capsules daily. Containing ALA 1.6 g).
Sponsored by
University of Guadalajara
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring PUFA omega 3, Obesity, Low-grade chronic inflammation, Specialized-proresolving mediators, Inflammation resolution

Eligibility Criteria

25 Years - 59 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Guadalajara (CUCS)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Intervention group

Control group

Arm Description

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 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)

Outcomes

Primary Outcome Measures

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).
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).
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)

Secondary Outcome Measures

Full Information

First Posted
September 22, 2021
Last Updated
October 3, 2021
Sponsor
University of Guadalajara
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1. Study Identification

Unique Protocol Identification Number
NCT05068557
Brief Title
EPICO: (Study for the Pro-resolution of Chronic Inflammation in Obesity. Original Acronym From Spanish)
Acronym
EPICO
Official Title
Dietary Intervention Supplemented With PUFA Omega-3 Fatty Acids on the Pro-resolving Capacity in Subjects With Obesity.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 24, 2021 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Guadalajara

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
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: Through the conversion of EPA and DHA to specialized pro-resolving mediators (SPMs) such as resolvins (E and D) determined by an ex vivo assay Through the study of the involved enzyme coding-genes in the previously mentioned conversion Through the study of the activation of specific membrane receptors (FFAR4) 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: Identification of genetic markers relevant to the treatment of obesity and its comorbidities Bases for new strategies aimed at reducing chronic low-grade inflammation inherent in obesity Useful information on gene-nutrient interaction for the public and private sector in the field of genetic testing Study population benefited from the results of the intervention and the information of their genetic and biochemical profiles Data from this study would strengthen the inflammatory knowledge of obesity comorbidities from distinct standpoints

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Chronic Inflammation
Keywords
PUFA omega 3, Obesity, Low-grade chronic inflammation, Specialized-proresolving mediators, Inflammation resolution

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Double-blind randomized parallel clinical trial
Masking
ParticipantInvestigator
Masking Description
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.
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Active Comparator
Arm Description
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)
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
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)
Intervention Type
Dietary Supplement
Intervention Name(s)
Dietary plan along with fish oil capsules (3 capsules daily. Containing EPA+DHA: 1.8 g).
Other Intervention Name(s)
Dietary intervention along with fish oil
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Dietary plan along with chia/linseed oil capsules (3 capsules daily. Containing ALA 1.6 g).
Other Intervention Name(s)
Placebo
Intervention Description
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).
Primary Outcome Measure Information:
Title
Resolvin E1 and D1 secretion under stimulation conditions (ex vivo).
Description
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
Title
Genetic analysis of Single Nucleotide Polymorphism (SNPs) involved in the synthesis of specialized pro-resolving mediators (SPMs).
Description
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
Title
Analysis of the activation of FFAR4 in PBMCs
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Erika Martinez-Lopez, PhD
Phone
+523310585200
Ext
33644
Email
erikamtz@yahoo.com.mx
Facility Information:
Facility Name
University of Guadalajara (CUCS)
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44340
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erika Martinez-Lopez, PhD
Phone
5210585200
Ext
33644
Email
erikamtz27@yahoo.com.mx
First Name & Middle Initial & Last Name & Degree
Roberto Rodriguez-Echevarria, PhD
Phone
+523310585200
Ext
34283
Email
roberto.rodriguez@academico.udg.mx

12. IPD Sharing Statement

Citations:
PubMed Identifier
17497447
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. doi: 10.1080/08860220601184092.
Results Reference
background
PubMed Identifier
27531277
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.
Results Reference
background
PubMed Identifier
31829100
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.
Results Reference
background
PubMed Identifier
31492430
Citation
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.
Results Reference
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EPICO: (Study for the Pro-resolution of Chronic Inflammation in Obesity. Original Acronym From Spanish)

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