跳至主要内容
临床试验/NCT04894344
NCT04894344已完成不适用

Education to Decrease in Sodium Intake in University Students Evaluated With 24 Hour Urinary Sodium Excretion: Randomized Controlled Trial

Universidad Autonoma de Baja California1 个研究点 分布在 1 个国家目标入组 196 人开始时间: 2020年10月28日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
196
试验地点
1
主要终点
24-hour urine sodium excretion

研究概览

简要总结

WHO identifies as an important risk factor and potentially modifiable to high sodium intake (>2g/day 5g salt/day). Also, an insufficient consumption of potassium ( 3.5 g/day).Therefore, the results of this research could be the regional basis that is required to generate evidence, that designs strategies and recommendations for the prevention or decrease in the progression of high blood pressure. The reduction in the consumption of salt in the diet could comply with the recommendations established by international agencies. In addition, to favor the beginning of lifestyle changes, as well as other modifications that will have a positive impact on health.In population highly vulnerable to the campaigns of large industries that favor the consumption of processed food.

However, it is unknown what is the effect of reducing foods high in sodium in populations in different regions of Mexico, estimated by 24 hour urine sodium excretion.

Therefore, the present study aims to answer the following questions:

What impact does an intervention aimed at the decrease in sodium intake, in young university students on blood pressure and the quantification of the excretion of sodium and urinary potassium of 24h? What is the association between body mass index, blood pressure and sodium reduction in the intervention vs control group? To assess the impact of an intervention aimed at reducing sodium intake through education as general recommendations for limiting specific foods high in sodium, in university students on blood pressure and quantification of urinary sodium and potassium excretion of 24h.

Specific objectives Assess sodium intake between the intervention group and the control group by estimating 24-hour urinary sodium excretion.

secundary objectives Evaluate the effect between the intervention group and the control group on blood pressure.

To assess the levels of potassium excretion in the intervention and control groups.

To evaluate the association between body mass index, blood pressure and sodium reduction in the intervention and control groups.

详细描述

According to reports from the World Health Organization (WHO) in 2015, the prevalence of hypertension in the world is 1.13 billion people, representing 1 in 4 men and 1 in 5 women (WHO, 2019). In the Americas, every year 1.6 million people die from cardiovascular disease and it has been reported that 20-40% of the adult population suffer hypertension, representing 250 million people affected.

High salt intake (NaCl) is considered an essential risk factor in the development and progression of hypertension.In addition, several studies indicate that sodium in the diet is directly associated with blood pressure.Deleterious effects of high sodium intake associated with endothelial damage have also been reported in normotensive individuals independent of high blood pressure , reduced endothelial function and microvascular reactivity due to oxidative stress.Likewise, a decrease in the nitric oxide of the endothelium has been described that precedes the development of atherosclerotic plaques, which is known through a mechanism where nitric oxide inhibits platelet aggregation, the adhesion of platelets to collagen fibers and other adhesive proteins, as well as the stimulation of adipocyte hypertrophy by increasing the enzymatic activity of leptin and lipogenic enzymes .With type 2 diabetes mellitus (DM2) and increased insulin resistance through hemodynamic changes in the kidneys by sustained sodium reabsorption.In addition, high salt intake has also been associated with kidney disease, osteoporosis, kidney stone formation and stomach cancer.Recently, as a potential modulator of inflammatory and autoimmune diseases through direct and indirect mechanisms of cellular immunity.Therefore, international organizations recommend decreasing sodium intake in the diet. The WHO recommends that sodium intake be 2000 mg/d (equivalent to 5g of salt) and potassium intake 3.5 g/d in adults, to prevent chronic diseases such as hypertension, risk of heart disease and stroke.

Methodology Study design: a randomized controlled, parallel-group, prospective trial was conducted.

Sample: n= 114, undergraduate students from the Autonomous University of Baja California.

For the sample size of the comparison of two repeated averages in two different groups of participants.Public-Public Software was used for its calculationGRANMO developed by the URLEC Consortium of the research groups on Cardiovascular Risk and Nutrition and on Epidemiology and Cardiovascular Genetics of the IMIM-Hospital del Mar Research Program on Inflammatory and Cardiovascular Processes.

研究设计

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

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Young men and women 18-40 years of age with diastolic blood pressure <90 and systolic blood pressure < 130.

排除标准

  • •Chronic non-hypertensive diseases
  • •Physical disability
  • •Subjects under treatment with diuretics
  • •Pregnant women, lactating or in their menstrual cycle
  • •High performance athletes

研究组 & 干预措施

Educational program

Experimental

Participants will be randomly assigned. Intervention Group: 57 participants Each participant will receive the same educational information throughout the study, each week a newsletter will be provided with recommendations and information that teaches them to choose low-sodium foods for 4 weeks.

Urine samples of 24 h before and after the Intervention will be analyzed.

干预措施: Education group (Behavioral)

Control group

No Intervention

Participants will be randomly assigned. Control group:57 participants Follow-up for 4 weeks. Urine samples of 24 h before and after the educational program will be analyzed.

结局指标

主要结局

24-hour urine sodium excretion

时间窗: up to 4 weeks

mmol/l

blood pressure

时间窗: up to 4 weeks

mmHg

次要结局

  • 24-hour urine potassium excretion(up to 4 weeks)
  • Physical activity(up to 4 weeks)

研究者

发起方
Universidad Autonoma de Baja California
申办方类型
Other
责任方
Principal Investigator
主要研究者

Naysin Yaheko Pardo Buitimea

Professor

Universidad Autonoma de Baja California

研究点 (1)

Loading locations...

相似试验