Education to Decrease in Sodium Intake in University Students Evaluated With 24 Hour Urinary Sodium Excretion: Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 196
- Locations
- 1
- Primary Endpoint
- 24-hour urine sodium excretion
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Young men and women 18-40 years of age with diastolic blood pressure <90 and systolic blood pressure < 130.
Exclusion Criteria
- •Chronic non-hypertensive diseases
- •Physical disability
- •Subjects under treatment with diuretics
- •Pregnant women, lactating or in their menstrual cycle
- •High performance athletes
Arms & Interventions
Educational program
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.
Intervention: Education group (Behavioral)
Control group
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.
Outcomes
Primary Outcomes
24-hour urine sodium excretion
Time Frame: up to 4 weeks
mmol/l
blood pressure
Time Frame: up to 4 weeks
mmHg
Secondary Outcomes
- 24-hour urine potassium excretion(up to 4 weeks)
- Physical activity(up to 4 weeks)
Investigators
Naysin Yaheko Pardo Buitimea
Professor
Universidad Autonoma de Baja California
