Clinical trial NCT02202265: Polymorphisms in CD36 and STAT3 Genes and Different Dietary Interventions Among Patients With Coronary Artery Disease
Official title: Effect of Polymorphisms in CD36 and STAT3 Genes on Different Dietary Interventions Among Patients With Coronary Artery Disease: a Randomized Clinical Trial With a Nutrigenetic Approach
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Heart Diseases
Lead sponsor: Instituto de Cardiologia do Rio Grande do Sul
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
name: Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil
First posted: 2014-07-28
Enrollment: 204
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: A randomized clinical trial with a nutrigenetic approach among patients ≥ 40 years diagnosed with CAD. Randomization will be made in blocks from a list of random numbers generated by site www.randomization.org (sealed opaque envelopes). A questionnaire with demographic and clinical data will be applied; systolic and diastolic blood pressure, waist, hip and neck circumferences, height and weight will be assessed. Nutrients intake will be assessed through a food diary. Laboratory evaluation will consist of lipid profile (LDL-cholesterol, HDL-cholesterol and total cholesterol, serum triglycerides), glycemic profile (fasting plasma glucose, glycated hemoglobin) and inflammatory profile (high-sensitivity C-reactive protein, fibrinogen, TNF-alpha, interleukin-6 and interleukin-10). Genotyping will be made by TaqMan SNP Genotyping Assay®. Patients will be randomized in three groups: Group 1 Intervention \[Supplementation with nuts (SN)\]: standard dietary guidelines + 30g of nuts a day; Group 2 Intervention \[Supplementation with olive oil (SAO)\]: standard dietary guidelines + 30ml of olive oil a day; Group 3 \[Control diet (CO)\]: standard dietary guidelines. Patients will be followed for three months (12 weeks) and the primary endpoint will be the change in LDL-cholesterol. The follow-up visits will be made at 30 days, 60 days and 90 days (final visit).

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with coronary arterial disease.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: LDL
timeFrame: twelve weeks
Secondary outcomes:
measure: TC
timeFrame: twelve weeks
measure: NHDL
timeFrame: twelve weeks
measure: HDL
timeFrame: twelve weeks
measure: TG
timeFrame: twelve weeks
measure: TyG index
timeFrame: twelve weeks
measure: HbA1C
timeFrame: twelve weeks
measure: FG
timeFrame: twelve weeks
measure: Insulin
timeFrame: twelve weeks
measure: HOMA-IR
timeFrame: twelve weeks
measure: inflammatory profile
timeFrame: twelve weeks
measure: BW
timeFrame: twelve weeks
measure: BMI
timeFrame: twelve weeks
measure: WC
timeFrame: twelve weeks
measure: NC
timeFrame: twelve weeks
measure: LAP index
timeFrame: twelve weeks
measure: DAAT index
timeFrame: twelve weeks
measure: VAI index
timeFrame: twelve weeks
measure: PFA
timeFrame: twelve weeks
measure: Mon
timeFrame: twelve weeks
measure: rs1761667 G>A
timeFrame: baseline
measure: rs8069645 A>G
timeFrame: baseline
measure: Interaction diet * genotype
timeFrame: twelve weeks
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Instituto de Cardiologia/Fundação Universitária de Cardiologia (IC/FUC)
state: Rio Grande Do Sul
Study officials:
affiliation: Instituto de Cardiologia/Fundação Universitária de Cardiologia (IC/FUC)
name: Aline Marcadenti, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto de Cardiologia/Fundação Universitária de Cardiologia (IC/FUC)
name: Vera L Portal, PhD
role: STUDY_DIRECTOR
affiliation: Instituto de Cardiologia/Fundação Universitária de Cardiologia
name: Melissa M Markoski, PhD
role: STUDY_DIRECTOR
affiliation: Instituto de Cardiologia/Fundação Universitária de Cardiologia
name: Alexandre S Quadros, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.