Coronary Artery Disease
Conditions
Keywords
Heart Diseases
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).
Interventions
DIETARY_SUPPLEMENTOlive oil
30ml a day of olive oil
DIETARY_SUPPLEMENTNuts
30g a day of nuts
DIETARY_SUPPLEMENTControl diet
Diet based on standard guidelines
Sponsors
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil
Instituto de Cardiologia do Rio Grande do Sul
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| LDL | twelve weeks | LDL-cholesterol, in mg/dL |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| NHDL | twelve weeks | non-HDL-cholesterol, in mg/dL |
| HDL | twelve weeks | HDL-cholesterol, in mg/dL |
| TG | twelve weeks | serum triglyceride, in mg/dL |
| TyG index | twelve weeks | Triglycerides/fasting glucose index, calculated according to (fasting triglycerides \[mg/dL\] x fasting glucose \[mg/dL\])/2 |
| HbA1C | twelve weeks | glycated hemoglobin (HbA1C), in % |
| FG | twelve weeks | fasting glucose, in mg/dL |
| Insulin | twelve weeks | serum insulin, in UI/mL |
| HOMA-IR | twelve weeks | Homeostatic Model Assessment for Insulin Resistance (HOMA-IR), calculated according to fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5 |
| inflammatory profile | twelve weeks | CRP-us, in mg/dL; IL-6, in mg/dL; IL-10, in mg/dL |
| BW | twelve weeks | body weight, in kg; |
| TC | twelve weeks | total cholesterol (TC), in mg/dL) |
| WC | twelve weeks | waist circumference, in cm |
| NC | twelve weeks | neck circumference, in cm |
| LAP index | twelve weeks | Lipid Accumulation Product Index (in cm.mmol.l), calculated for men: men (waist circumference \[WC\] - 65) x triglycerides (TG), and women (WC - 58) x TG |
| DAAT index | twelve weeks | Deep-Abdominal-Adipose-Tissue Index (in cm2), calculated for men (- 382.9 + \[1.09 x weight\] + \[6.04 x waist circumference (WC)\] + \[- 2.29 x body mass index (BMI)\]) and women (- 278 + \[- 0.86 x weight\] + \[5.19 x WC\]) |
| VAI index | twelve weeks | Visceral Adiposity Index (log), calculated for men (waist circumference (WC)/\[39 + (1.88 x body mass index (BMI)) x (triglycerides (TG)/1.03) x (1.31/HDL)\]) and women (WC/\[36.58 + (1.89 x BMI) x (TG/0.81) x (1.53/HDL)\]) |
| PFA | twelve weeks | plasma fatty acids, in percentage |
| Mon | twelve weeks | plasma monocytes, in percentage |
| rs1761667 G>A | baseline | Polymorphism rs1761667 G\>A in the CD36 gene |
| rs8069645 A>G | baseline | Polymorphism rs8069645 A\>G in the STAT3 gene |
| Interaction diet * genotype | twelve weeks | Interaction between dietary intervention, rs1761667 and rs8069645 |
| BMI | twelve weeks | body mass index (BMI), in kg/m2, calculated according to weight (kg)/height\*height (m) |
Countries
Brazil
Outcome results
None listed