Ignite Creation Date:
2024-05-06 @ 3:05 AM
Last Modification Date:
2024-10-26 @ 11:28 AM
Study NCT ID:
NCT02202265
Status:
UNKNOWN
Last Update Posted:
2020-09-10
First Post:
2014-07-18
Brief Title:
Polymorphisms in CD36 and STAT3 Genes and Different Dietary Interventions Among Patients With Coronary Artery Disease
Sponsor:
Instituto de Cardiologia do Rio Grande do Sul
Organization:
Instituto de Cardiologia do Rio Grande do Sul
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2020-09
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GENUTRI
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 AG 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 GA 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 andor 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
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 andor 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 wwwrandomizationorg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None