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

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ClinicalTrials.gov Identifier: NCT02202265
Recruitment Status : Active, not recruiting
First Posted : July 28, 2014
Last Update Posted : September 10, 2020
Sponsor:
Collaborators:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil
Information provided by (Responsible Party):
Instituto de Cardiologia do Rio Grande do Sul

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.


Condition or disease Intervention/treatment Phase
Coronary Artery Disease Dietary Supplement: Olive oil Dietary Supplement: Nuts Dietary Supplement: Control diet Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 204 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : August 2014
Actual Primary Completion Date : June 17, 2016
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Olive oil

Arm Intervention/treatment
Active Comparator: Control diet (standard dietary)
Patients will receive a control diet based on standard dietary guidelines
Dietary Supplement: Control diet
Diet based on standard guidelines

Experimental: Olive oil (30ml a day)
Patients will receive a control diet based on standard dietary guidelines + 30ml of olive oil a day
Dietary Supplement: Olive oil
30ml a day of olive oil

Experimental: Nuts (30g a day)
Patients will receive a control diet based on standard dietary guidelines plus 30g of nuts a day
Dietary Supplement: Nuts
30g a day of nuts




Primary Outcome Measures :
  1. LDL [ Time Frame: twelve weeks ]
    LDL-cholesterol, in mg/dL


Secondary Outcome Measures :
  1. TC [ Time Frame: twelve weeks ]
    total cholesterol (TC), in mg/dL)

  2. NHDL [ Time Frame: twelve weeks ]
    non-HDL-cholesterol, in mg/dL

  3. HDL [ Time Frame: twelve weeks ]
    HDL-cholesterol, in mg/dL

  4. TG [ Time Frame: twelve weeks ]
    serum triglyceride, in mg/dL

  5. TyG index [ Time Frame: twelve weeks ]
    Triglycerides/fasting glucose index, calculated according to (fasting triglycerides [mg/dL] x fasting glucose [mg/dL])/2

  6. HbA1C [ Time Frame: twelve weeks ]
    glycated hemoglobin (HbA1C), in %

  7. FG [ Time Frame: twelve weeks ]
    fasting glucose, in mg/dL

  8. Insulin [ Time Frame: twelve weeks ]
    serum insulin, in UI/mL

  9. HOMA-IR [ Time Frame: twelve weeks ]
    Homeostatic Model Assessment for Insulin Resistance (HOMA-IR), calculated according to fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5

  10. inflammatory profile [ Time Frame: twelve weeks ]
    CRP-us, in mg/dL; IL-6, in mg/dL; IL-10, in mg/dL

  11. BW [ Time Frame: twelve weeks ]
    body weight, in kg;

  12. BMI [ Time Frame: twelve weeks ]
    body mass index (BMI), in kg/m2, calculated according to weight (kg)/height*height (m)

  13. WC [ Time Frame: twelve weeks ]
    waist circumference, in cm

  14. NC [ Time Frame: twelve weeks ]
    neck circumference, in cm

  15. LAP index [ Time Frame: 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

  16. DAAT index [ Time Frame: 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])

  17. VAI index [ Time Frame: 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)])

  18. PFA [ Time Frame: twelve weeks ]
    plasma fatty acids, in percentage

  19. Mon [ Time Frame: twelve weeks ]
    plasma monocytes, in percentage

  20. rs1761667 G>A [ Time Frame: baseline ]
    Polymorphism rs1761667 G>A in the CD36 gene

  21. rs8069645 A>G [ Time Frame: baseline ]
    Polymorphism rs8069645 A>G in the STAT3 gene

  22. Interaction diet * genotype [ Time Frame: twelve weeks ]
    Interaction between dietary intervention, rs1761667 and rs8069645



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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02202265


Locations
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Brazil
Instituto de Cardiologia/Fundação Universitária de Cardiologia (IC/FUC)
Porto Alegre, Rio Grande Do Sul, Brazil, 90.620-001
Sponsors and Collaborators
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
Investigators
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Principal Investigator: Aline Marcadenti, PhD Instituto de Cardiologia/Fundação Universitária de Cardiologia (IC/FUC)
Study Director: Vera L Portal, PhD Instituto de Cardiologia/Fundação Universitária de Cardiologia (IC/FUC)
Study Director: Melissa M Markoski, PhD Instituto de Cardiologia/Fundação Universitária de Cardiologia
Study Director: Alexandre S Quadros, PhD Instituto de Cardiologia/Fundação Universitária de Cardiologia
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Instituto de Cardiologia do Rio Grande do Sul
ClinicalTrials.gov Identifier: NCT02202265    
Other Study ID Numbers: 48612013
First Posted: July 28, 2014    Key Record Dates
Last Update Posted: September 10, 2020
Last Verified: September 2020
Keywords provided by Instituto de Cardiologia do Rio Grande do Sul:
Heart Diseases
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases