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

Coronary Artery Disease Clinical Trial

— GENUTRI  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02202265
• Other study ID #: 48612013
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 2014
• Est. completion date: December 31, 2020

Study information

• Verified date: September 2020
• Source: Instituto de Cardiologia do Rio Grande do Sul
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 204
• Est. completion date: December 31, 2020
• Est. primary completion date: June 17, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Dietary Supplement:
• Olive oil
30ml a day of olive oil
• Nuts
30g a day of nuts
• Control diet
Diet based on standard guidelines

Locations

Country	Name	City	State
Brazil	Instituto de Cardiologia/Fundação Universitária de Cardiologia (IC/FUC)	Porto Alegre	Rio Grande Do Sul

Sponsors (3)

Lead Sponsor	Collaborator
Instituto de Cardiologia do Rio Grande do Sul	Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LDL	LDL-cholesterol, in mg/dL	twelve weeks
Secondary	TC	total cholesterol (TC), in mg/dL)	twelve weeks
Secondary	NHDL	non-HDL-cholesterol, in mg/dL	twelve weeks
Secondary	HDL	HDL-cholesterol, in mg/dL	twelve weeks
Secondary	TG	serum triglyceride, in mg/dL	twelve weeks
Secondary	TyG index	Triglycerides/fasting glucose index, calculated according to (fasting triglycerides [mg/dL] x fasting glucose [mg/dL])/2	twelve weeks
Secondary	HbA1C	glycated hemoglobin (HbA1C), in %	twelve weeks
Secondary	FG	fasting glucose, in mg/dL	twelve weeks
Secondary	Insulin	serum insulin, in UI/mL	twelve weeks
Secondary	HOMA-IR	Homeostatic Model Assessment for Insulin Resistance (HOMA-IR), calculated according to fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5	twelve weeks
Secondary	inflammatory profile	CRP-us, in mg/dL; IL-6, in mg/dL; IL-10, in mg/dL	twelve weeks
Secondary	BW	body weight, in kg;	twelve weeks
Secondary	BMI	body mass index (BMI), in kg/m2, calculated according to weight (kg)/height*height (m)	twelve weeks
Secondary	WC	waist circumference, in cm	twelve weeks
Secondary	NC	neck circumference, in cm	twelve weeks
Secondary	LAP index	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	twelve weeks
Secondary	DAAT index	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])	twelve weeks
Secondary	VAI index	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)])	twelve weeks
Secondary	PFA	plasma fatty acids, in percentage	twelve weeks
Secondary	Mon	plasma monocytes, in percentage	twelve weeks
Secondary	rs1761667 G>A	Polymorphism rs1761667 G>A in the CD36 gene	baseline
Secondary	rs8069645 A>G	Polymorphism rs8069645 A>G in the STAT3 gene	baseline
Secondary	Interaction diet * genotype	Interaction between dietary intervention, rs1761667 and rs8069645	twelve weeks