ObesityEPICONCT05068557
EPICO: (Study for the Pro-resolution of Chronic Inflammation in Obesity. Original Acronym From Spanish)
A study testing 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 people with Obesity and Chronic Inflammation, run by University of Guadalajara at 1 site in Mexico.
Trial 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… Read more about this study
- Who is it for?
- Ages 25 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Chronic Inflammation
- What is being tested?
- 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).
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteMexico
- Study dates
- 24 Sep 2021to Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
University of Guadalajara (CUCS)
Guadalajara, Jalisco, 44340
Erika Martinez-Lopez, PhD, 5210585200 ext. 33644, erikamtz27@yahoo.com.mx
Roberto Rodriguez-Echevarria, PhD, +523310585200 ext. 34283, roberto.rodriguez@academico.udg.mx
About this study
Official 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.
Read the 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
- Conditions
- Obesity, Chronic Inflammation
- Being tested
- 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).
- Keywords
- PUFA omega 3, Obesity, Low-grade chronic inflammation, Specialized-proresolving mediators, Inflammation resolution
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary plan along with fish oil capsules (3 capsules daily. Containing EPA+DHA: 1.8 g).Dietary supplement
Also called 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: EPA+DHA: 1.8 g.
Dietary plan along with chia/linseed oil capsules (3 capsules daily. Containing ALA 1.6 g).Dietary supplement
Also called Placebo
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).
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Dietary Supplement: Dietary plan along with chia/linseed oil capsules (3 capsules daily. Containing ALA 1.6 g). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2021
- Study start24 Sep 2021
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind randomized parallel clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Guadalajara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ERIKA MARTINEZ-LOPEZ, University of Guadalajara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05068557
- Sponsor's protocol ID
- CI03221
- Acronym
- EPICO
- Status last verified
- Oct 2021
- First submitted
- 22 Sep 2021
- Last updated
- 6 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 17497447Polus 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.
PubMed 27531277Souza 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.
PubMed 31829100Barden 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.
PubMed 31492430
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Intervention Supplemented With PUFA Omega-3 Fatty Acids on the Pro-resolving Capacity in Subjects With Obesity.
- ClinicalTrials.gov ID
- NCT05068557
- Acronym / sponsor ID
- EPICO / CI03221
- Conditions
- Obesity, Chronic Inflammation
- Keywords
- PUFA omega 3, Obesity, Low-grade chronic inflammation, Specialized-proresolving mediators, Inflammation resolution
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of GuadalajaraUniversity, hospital or other
- Study start
- 24 Sep 2021 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 6 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Double-blind randomized parallel clinical trial
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Active comparator | 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 fish oil (3 capsules daily. Containing EPA+DHA: 1.8 g). (n=40) |
| Control group | Placebo comparator | Dietary Supplement: Dietary plan along with chia/linseed oil capsules (3 capsules daily. Containing ALA 1.6 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) |
Who may qualify
- Ages
- 25 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary plan along with fish oil capsules (3 capsules daily. Containing EPA+DHA: 1.8 g).Also: Dietary intervention along with fish oilSubects 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. | Dietary supplement | Intervention group |
| Dietary plan along with chia/linseed oil capsules (3 capsules daily. Containing ALA 1.6 g).Also: PlaceboSubects 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). | Dietary supplement | Control group |
Primary outcome
Resolvin E1 and D1 secretion under stimulation conditions (ex vivo).
Time frame: 12 weeks
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).
Time frame: 12 weeks
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
Time frame: 12 weeks
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2021.
- Background: PubMed 17497447Rasic-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.
- Background: PubMed 27531277Polus 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.
- Background: PubMed 31829100Souza 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.
- Background: PubMed 31492430Barden 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 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 people with Obesity and Chronic Inflammation, run by University of Guadalajara at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Erika Martinez-Lopez, PhD (+523310585200 ext. 33644, erikamtz@yahoo.com.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resolvin E1 and D1 secretion under stimulation conditions (ex vivo). (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05068557, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2021.