Polymorphisms in CD36 and STAT3 Genes and Different Dietary Interventions Among Patients With Coronary Artery Disease

NCT02202265 | Unknown

• 1 other identifier: 48612013
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Cardiovascular diseases are the major health problem worldwide and the understanding of genetic contributions on the development of cardiovascular diseases is increasing significantly. The CD36 is a protein associated with uptake of oxidized forms of LDL and the single nucleotide polymorphism (SNP) rs1761667 A/G in the CD36 gene is correlated with increased consumption of total fat. The transcription factor STAT3 is released during the inflammatory acute phase response and the SNP rs8069645 G/A in the STAT3 gene is associated with abdominal obesity and higher intake of saturated fat. Studies have been shown the benefits of the Mediterranean diet in secondary prevention of cardiovascular disease and these dietary patterns have been often studied with nutrigenetic approach; these studies, however, are often limited to European populations, making it difficult to generalize to different populations. Hypothesis: Different dietary approaches may similarly influence in modifying metabolic, inflammatory and anthropometric profile, especially among patients with coronary arterial disease (CAD). The genetic interaction with environmental factors such as the nutrient intake, and the prescription of a different diet according to individual genotype, could influence the development and/or the treatment of cardiovascular diseases. Objective: To evaluate the effect of three dietary approaches on metabolic, inflammatory and anthropometric profile in patients with CAD and possible interactions with polymorphisms in CD36 and STAT3 genes.

Conditions

Coronary Artery Disease

Keywords

Heart Diseases

Outcome Measures

Primary Outcomes (1)

• LDL

  LDL-cholesterol, in mg/dL

  twelve weeks

Secondary Outcomes (22)

• TC

  twelve weeks

• NHDL

  twelve weeks

• HDL

  twelve weeks

• TG

  twelve weeks

• TyG index

  twelve weeks

Study Arms (3)

Control diet (standard dietary)

ACTIVE COMPARATOR

Patients will receive a control diet based on standard dietary guidelines

Dietary Supplement: Control diet

Olive oil (30ml a day)

EXPERIMENTAL

Patients will receive a control diet based on standard dietary guidelines + 30ml of olive oil a day

Dietary Supplement: Olive oil

Nuts (30g a day)

EXPERIMENTAL

Patients will receive a control diet based on standard dietary guidelines plus 30g of nuts a day

Dietary Supplement: Nuts

Interventions

Olive oil DIETARY_SUPPLEMENT

30ml a day of olive oil

Olive oil (30ml a day)

Nuts DIETARY_SUPPLEMENT

30g a day of nuts

Nuts (30g a day)

Control diet DIETARY_SUPPLEMENT

Diet based on standard guidelines

Control diet (standard dietary)

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with coronary arterial disease.

You may not qualify if:

• Psychiatric disease;
• Morbid obesity (BMI ≥ 40mg/m2);
• Expectancy of life less than 6 months;
• Pregnancy or lactation;
• Renal failure (in dialysis);
• Congestive heart failure;
• Prior organ transplantation;
• Patients in wheelchair;
• Use of vitamin/nutritional supplements;
• Chronic use of non steroidal anti-inflammatory drugs;
• Participation in another experimental study.

Sponsors & Collaborators

• Instituto de Cardiologia do Rio Grande do Sul: lead
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator
• Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil: collaborator

Study Sites (1)

Instituto de Cardiologia/Fundação Universitária de Cardiologia (IC/FUC)

Porto Alegre, Rio Grande do Sul, 90.620-001, Brazil

Location

Related Publications (3)

• Dos Santos JL, Portal VL, Markoski MM, de Quadros AS, Bersch-Ferreira A, Marcadenti A. Effect of pecan nuts and extra-virgin olive oil on glycemic profile and nontraditional anthropometric indexes in patients with coronary artery disease: a randomized clinical trial. Eur J Clin Nutr. 2022 Jun;76(6):827-834. doi: 10.1038/s41430-021-01045-7. Epub 2021 Nov 22.

  PMID: 34811509 DERIVED

• Campos VP, Portal VL, Markoski MM, Quadros AS, Bersch-Ferreira AC, Garavaglia J, Marcadenti A. Effects of a healthy diet enriched or not with pecan nuts or extra-virgin olive oil on the lipid profile of patients with stable coronary artery disease: a randomised clinical trial. J Hum Nutr Diet. 2020 Jun;33(3):439-450. doi: 10.1111/jhn.12727. Epub 2019 Dec 19.

  PMID: 31856379 DERIVED

• Portal VL, Markoski MM, Quadros AS, Garofallo S, Santos JL, Oliveira A, Wechenfelder C, Campos VP, Souza PA, Machado L, Marcadenti A. Effect of polymorphisms in the CD36 and STAT3 genes on different dietary interventions among patients with coronary artery disease: study protocol for a randomized controlled trial. Trials. 2016 Sep 5;17(1):437. doi: 10.1186/s13063-016-1564-1.

  PMID: 27596284 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Heart Diseases

Interventions

Olive Oil; Nuts

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fats, Unsaturated; Plant Oils; Oils; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Aline Marcadenti, PhD

  Instituto de Cardiologia/Fundação Universitária de Cardiologia (IC/FUC)

  PRINCIPAL INVESTIGATOR

• Vera L Portal, PhD

  Instituto de Cardiologia/Fundação Universitária de Cardiologia (IC/FUC)

  STUDY DIRECTOR

• Melissa M Markoski, PhD

  Instituto de Cardiologia/Fundação Universitária de Cardiologia

  STUDY DIRECTOR

• Alexandre S Quadros, PhD

  Instituto de Cardiologia/Fundação Universitária de Cardiologia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2014
• First Posted: July 28, 2014
• Study Start: August 1, 2014
• Primary Completion: June 17, 2016
• Study Completion: December 31, 2020
• Last Updated: September 10, 2020

Record last verified: 2020-09

Locations

BR (1)