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临床试验/NCT01604681
NCT01604681Unknown不适用

The Effect of Flaxseed Oil Supplementation on Biomarkers, Quality of Life and Cognitive Function in Hypertensive and Dyslipidemic Subjects With or Without the C677T and A1298C Polymorphisms in MTHFR Gene in Different Municipalities of Rio de Janeiro

Universidade Federal do Rio de Janeiro1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2011年1月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
200
试验地点
1
主要终点
Polymorphisms

研究概览

简要总结

The purpose of this study is to evaluate the effect of supplementation with flaxseed oil combined with a nutritional counseling in reducing cardiovascular risk factors in homocysteine , biomarkers of inflammation, oxidative stress, improving quality of life and cognitive decline in hypertensive and dyslipidemic genotyped for the C677T and A1298C polymorphisms of methylenetetrahydrofolate reductase gene.

详细描述

Epidemiological data show that there is a decline in death from cardiovascular disease (CVD) in the state of Rio de Janeiro, but this did not happen in the cities of Itaperuna, Niterói and Volta Redonda, in spite of presenting different epidemiological characteristics, still have high rates of death CVD. What led to our interest in investigating these municipalities. Our goal is to evaluate the effect of supplementation with flaxseed oil combined with nutritional counseling in reducing cardiovascular risk factors in homocysteine, biomarkers of inflammation, oxidative stress, improving quality of life and cognitive decline in hypertensive individuals dyslipidemic and genotyped for polymorphisms C677T and A1298C methylenetetrahydrofolate reductase gene (MTFHR). This is a clinical trial, double blind, placebo-controlled, randomized block, lasting three months. Study participants will be recruited from August 2011 to August 2013. Will be recruited at least 200 individuals in each city, considering possible losses and ensuring consistent results. Subjects will be randomized in blocks of 10, five patients in the group supplemented with linseed oil and five patients in the control group with placebo supplementation, ensuring proper distribution of the number of participants in the study groups. Will be collecting information on the socio-economic status of study participants through a structured questionnaire will be carried out assessment of food consumption - frequency of consumption and 24 hours, clinic - blood pressure, anthropometric - height, weight, waist circumference and BMI, body composition - bioelectrical impedance analysis, biochemical tests - lipid profile, blood glucose, insulin, homocysteine, serum folate concentrations in erythrocytes and, cobalamin, vitamin C, E and A, minerals - zinc, iron, copper and selenium, markers of oxidative stress and inflammatory response and molecular analysis - C677T and A1298C polymorphisms of methylenetetrahydrofolate reductase gene. It will also be diagnosed with depression and evaluation of physical activity and quality of life using questionnaires were previously validated. Our results demonstrate the effectiveness of supplementation with flaxseed oil, in reinforcing the results of nutritional counseling in reducing cardiovascular risk factors and biomarkers studied, besides adding to the knowledge about the interactions between markers of inflammation, oxidative stress with oil supplementation flaxseed and polymorphisms C677T and A1298C MTHFR gene, on which there are no reports in the literature.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
Double (Participant, Investigator)

入排标准

年龄范围
20 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of hypertension and/or dyslipidemia,
  • Have over 20 years,
  • Both sexes,
  • Any skin color and
  • Take part in the study by signing the consent form.

排除标准

  • Make use of some food or vitamin supplement,
  • HIV positive and cancer.

研究组 & 干预措施

placebo group

Placebo Comparator

3 g of powdered gelatin encapsulated in opaque capsules.

干预措施: Placebo (Dietary Supplement)

结局指标

主要结局

Polymorphisms

时间窗: Up to 3 months

To evaluate the effect of nutritional counseling associated with linseed oil supplementation on biomarkers estutados according to the C677T and A1298C polymorphisms of the MTHFR gene.

次要结局

  • Cognitive decline(Up to 3 months)
  • Quality of life(Up to 3 months)
  • Oxidative stress(Up to 3 months)
  • Lipid profile(Up to 3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ana Paula Alves Avelino

Principal Investigator

Universidade Federal do Rio de Janeiro

研究点 (1)

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