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

Instituto de Cardiologia do Rio Grande do Sul

Status: Unknown

Conditions: Coronary Artery Disease

Treatments: Dietary Supplement: Control diet; Dietary Supplement: Nuts; Dietary Supplement: Olive oil

Study type: Interventional

Funder types: Other

Identifiers

NCT02202265

48612013

Details and patient eligibility

About

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.

Full 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).

Enrollment: 204 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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204 participants in 3 patient groups

Control diet (standard dietary)

Active Comparator group

Description:

Patients will receive a control diet based on standard dietary guidelines

Treatment:

Dietary Supplement: Control diet

Olive oil (30ml a day)

Experimental group

Description:

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

Treatment:

Dietary Supplement: Olive oil

Nuts (30g a day)

Experimental group

Description:

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

Treatment:

Dietary Supplement: Nuts