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Report for Clinical Trial NCT02202265

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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

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.

NCT02202265 Coronary Artery Disease
MeSH:Coronary Artery Disease Myocardial Ischemia Coronary Disease
HPO:Coronary artery atherosclerosis Myocardial infarction

3 Interventions

Name: Olive oil

Description: 30ml a day of olive oil
Type: Dietary Supplement
Group Labels: 1

Olive oil (30ml a day)

Name: Nuts

Description: 30g a day of nuts
Type: Dietary Supplement
Group Labels: 1

Nuts (30g a day)

Name: Control diet

Description: Diet based on standard guidelines
Type: Dietary Supplement
Group Labels: 1

Control diet (standard dietary)


Primary Outcomes

Description: LDL-cholesterol, in mg/dL

Measure: LDL

Time: twelve weeks

Secondary Outcomes

Description: total cholesterol (TC), in mg/dL)

Measure: TC

Time: twelve weeks

Description: non-HDL-cholesterol, in mg/dL

Measure: NHDL

Time: twelve weeks

Description: HDL-cholesterol, in mg/dL

Measure: HDL

Time: twelve weeks

Description: serum triglyceride, in mg/dL

Measure: TG

Time: twelve weeks

Description: glycated hemoglobin (HbA1C), in %

Measure: HbA1C

Time: twelve weeks

Description: fasting glucose, in mg/dL

Measure: FG

Time: twelve weeks

Description: serum insulin, in UI/mL

Measure: Insulin

Time: twelve weeks

Description: Homeostatic Model Assessment for Insulin Resistance (HOMA-IR), calculated according to fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5

Measure: HOMA-IR

Time: twelve weeks

Description: CRP-us, in mg/dL; IL-6, in mg/dL; IL-10, in mg/dL

Measure: inflammatory profile

Time: twelve weeks

Description: body weight, in kg;

Measure: BW

Time: twelve weeks

Description: body mass index (BMI), in kg/m2, calculated according to weight (kg)/height*height (m)

Measure: BMI

Time: twelve weeks

Description: waist circumference, in cm

Measure: WC

Time: twelve weeks

Description: plasma fatty acids, in percentage

Measure: PFA

Time: twelve weeks

Description: plasma monocytes, in percentage

Measure: Mon

Time: twelve weeks

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There are 2 SNPs

SNPs


1 rs1761667

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.


2 rs8069645

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.



HPO Nodes


HPO: