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临床试验/NCT03915600
NCT03915600Unknown不适用

Evaluation of the Citotoxicity and Clicemic Control of Subject With Metabolic Syndrome Managed With Conventional Nutritional Tratment More Quinoa, Flaxseed or Borh Versus Conventional Nutrition

University of Guadalajara4 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2019年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
90
试验地点
4
主要终点
Changes in the number of micronuceli after 24 weeks

研究概览

简要总结

The Metabolic Syndrome (MS) is a set of anthropometric alterations and chronic-degenerative diseases, such as obesity, diabetes mellitus and arterial hypertension. Each one of the diseases and physiological alterations represents a risk factor that conditions in the medium or long term another incapacitating or limiting disease that reduces the quality of life of an individual.

Our country has a growing burden of morbidity and mortality due to diseases chronic-degenerative caused, for the most part, to the unhealthy lifestyle produced by multiple factors, such as social, economic, behavioral, environmental, among others. For this reason, it is important to plan, design and implement strategies that reduce, mitigate or control this public health problem in the population. The purpose of this study is to perform a nutritional intervention that includes food such as quinoa, flaxseed or both in subjects with metabolic syndrome and follow them up for six months. The impact of this intervention will be carried out through the measurement of cytotoxicity and glycemic control, this is with the micronucleus count and the estimation of glycosylated hemoglobin (Hba1c).

This document will explain in detail what is intended to be done by presenting the following sections:

In the approach of the problem and the justification, the metabolic syndrome will be described, its impact on the Mexican population, the interest and relevance of this research project.

In the background will be detailed what has been said and done in the different studies scientists regarding the consumption of quinoa and flaxseed. Methodology defines the strategy, conditions, clinical criteria, material and epidemiological and statistical methods for the management of subjects and information.

详细描述

The "strong pulse disease" was treated by acupuncture, phlebotomy and leeches from 2600 to c. Modern history began when in 1628 William Harvey described the circulatory system and in 1733 stephen hales made the first blood pressure measurement. In 1896 was recognized as a clinical entity, thanks to the invention of the sphygmomanometer by Riva-rocci and in 1913 janeway coined the term "hypertensive vascular disease". The metabolic syndrome was described since 1988 as syndrome x, with the intention of showing how the cardiovascular risk factors are grouped together: obesity, hyperglycemia, dyslipidemia and arterial hypertension. Earlier, in 1920, Kylin had described that diabetes, high blood pressure and gout were associated, but not related to cardiovascular disease. Syndrome x was later called insulin resistance syndrome and, finally, metabolic syndrome or cardiometabolic syndrome. By 1999, the world health organization reported what would be the first diagnostic criteria for the metabolic syndrome. Soon they were reason for criticism because they were considered impractical, because it was necessary to diagnose insulin resistance and microalbuminuria. From then to date numerous criteria have been reported, perhaps the most used to date, in adults they are the

3.- NCEP-ATPIII (from the third treatment panel of adults of the national cholesterol education program of the United States). The main trigger of this conglomerate of atherogenic, prothrombotic, proinflammatory and metabolic factors is obesity, in our country, the prevalence of overweight and obesity in adults increased from 62 to 70% in just five years. In the last century, in Mexico the energy density of the diet was increased by almost 24% (26% more carbohydrates and 36% more fat) and physical activity has been reduced In Mexico, the prevalence of metabolic syndrome in children and adolescents is 20% and is strongly linked to overweight and childhood obesity.

Mexicans are world leaders in obesity, since one in three Mexicans is overweight due to poor diet. In February 2012, the organization for cooperation and economic development (OECD) reported that Mexico was the second most overweight or obese country on a list that includes 40 nations, adding that three out of seven Mexicans have a waistline bigger than they should be. Chronic degenerative diseases have displaced infectious diseases as the main causes of mortality in Mexico. In 2011, 70 of every 100.00 people died from this disease in the country.

In Mexico, aguilar-salinas reported an age-adjusted prevalence of 13.6% with the criterion of the world health organization and 26.6% with the ncep-atpiii criterion in people between 20 and 69 years old, from the ensa survey. -2000; while González-Villalpando in the Diabetes Study of Mexico City reported prevalences of 39.9 and 59.9% for men and women, respectively, based on the criteria of the Ncep-ATP III.

In Mexico, diabetes is the leading cause of blindness acquired in the productive age; as well it is the first cause of non-traumatic amputations of the lower limbs and of chronic renal failure. Short and long-term complications require medical attention and specialized treatments, which means that your care entails overwhelmingly high costs. The Binomial insulin resistance/hyperinsulinemia are associated with a significant increase in cardiovascular morbidity and mortality expressed as atherosclerosis, acute cerebral, cardiac or peripheral ischemic syndromes, as well as other pathologies, which due to their coexistence and physiopathological co-responsibility has been called metabolic syndrome.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
30 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnostic of Metabolic Syndrome that meets at least one of the ATP-III criteria:
  • Abdominal obesity over 102cm for men and over 88cm for women
  • Triglycerides levels over 150mg/dl with or without treatment for dyslipidemia
  • c-HDL concentration under 40mg/dl for men and under 50mg/dl for women
  • Blood Pressure over 130/85mmHg
  • Fasting glucose levels over 100mg/dl with or without treatment

排除标准

  • Pregnant women
  • Subject with other degenerative chronic diseases does not include or consider it in ATP-III criteria for Metabolic Syndrome
  • Elimination Criteria
  • Subjects without oral mucosa samples
  • Subjects without A1c data
  • Subjects without addiction to treatment under 80% with quinoa, flaxseed or both and conventional diet

研究组 & 干预措施

Quinoa and Flaxseed

Experimental

Personalized diet added with quinoa and flaxseed

干预措施: Quinoa and Flaxseed (Other)

Normal diet

No Intervention

Personalized diet without dietary supplement

Quinoa

Experimental

Personalized diet added with quinoa

干预措施: Quinoa (Other)

Flaxseed

Experimental

Personalized diet added with Flaxseed

干预措施: Flaxseed (Other)

结局指标

主要结局

Changes in the number of micronuceli after 24 weeks

时间窗: 24 weeks

The number of micronuclei will be evaluated at baseline at 12 weeks and 24 weeks with Schmidt technique by Giemsa/wright and the entered values reflect the number of micronuclei at week 24

Changes in fasting glucose levels after 24 weeks of intervention with an added diet with quinoa or flaxseed or both or conventional diet

时间窗: 24 weeks

The fasting glucose levels will be evaluated at baseline, at 12 weeks and 24 weeks with enzymatic/colorimetric techniques and the entered values reflect the fasting glucose level at 24 weeks

Changes in glycosylated hemoglobin (A1C) after 24 weeks of intervention with an added diet with quinoa or flaxseed or both or conventional diet

时间窗: 24 weeks

Glycosylated hemoglobin will be evaluated at baseline, at 12 weeks and 24 weeks by high-pressure liquid chromatography (HPLC) and the entered values reflect the glycosylated hemoglobin at 24 weeks

次要结局

  • Body Weight(24 weeks)
  • Total Cholesterol(24 weeks)
  • High Density Lipoprotein(24 weeks)
  • Body Mass Index(24 weeks)
  • Waist Circumference(24 weeks)
  • Triglycerides levels(24 weeks)
  • Low Density Lipoproteins(24 weeks)
  • Blood pressure(24 weeks)

研究者

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

Ana Lilia Fletes Rayas

PROFESSOR ASSOCIATE TYPE A

University of Guadalajara

研究点 (4)

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