Clinical trial NCT04828655: Analysis of Bioparametric Measures for Correlating Daily Habits and Reducing Blood Pressure
Official title: Análisis de Medidas bioparamétricas Para Correlacionar Los hábitos Diarios y Reducir la tensión Arterial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Diet, Mediterranean
Cardiovascular Diseases
Exercise
Machine Learning
Overweight and Obesity
Body Composition
Triglyceride-Storage; Disease
Lead sponsor: University of Alicante
Sponsor class: OTHER
First posted: 2021-04-02
Enrollment: 36
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: To study the effects of the use of a mobile application plus recommendations based on a Mediterranean diet on the intake of micronutrients from natural sources (not drugs) on health indicators, cardiovascular parameters (blood pressure...), physical condition and body composition in a Spanish adult population.

Detailed description: In the Valencian Community, 93% of deaths appear to be related to (non-communicable) diseases such as: obesity, hypertension and diabetes. In 2013, cardiovascular diseases were the leading cause of death in women (34.4%) and the second in men (28.0%). There is a forecast that overweight and obesity will reach levels of 89% and 85% in men and women, respectively, by 2030. This will result in an increase in the obesity-related prevalence of coronary heart disease by 97%. The promotion of research on arterial hypertension and how it could be reduced is one of the basic pillars in decreasing the prevalence and incidence in the Spanish population. Research should anticipate and develop treatments and vaccines that prevent new scenarios of widespread infection.

Therefore, the main objective is to study the effects of the use of a mobile application plus recommendations based on a Mediterranean diet on the intake of micronutrients from natural sources (not drugs) on health indicators, cardiovascular parameters (blood pressure...), physical condition and body composition in the adult Spanish population.

Eligibility criteria: Inclusion Criteria:

* Over 40 years old
* Healthy.
* Blood pressure levels slightly elevated but less than 140 mm Hg and/or diastolic pressure less than 90 mm Hg.
* Smartphone access

Exclusion Criteria:

* Subjects with diseases.
* Consumption of drugs and/or supplements.
* Subjects with food intolerances/allergies.
* Subjects with muscle or joint injury.
* Subjects with impossibility to follow up the intervention.
* Refusal of informed consent

Primary outcomes:
measure: Cardiovascular variables; heart rate.
timeFrame: 9 months
measure: Cardiovascular variables; blood pressure.
timeFrame: 9 months
measure: Physical condition; time.
timeFrame: 9 months
measure: Body Composition - Bioimpedance
timeFrame: 9 months
measure: Weight
timeFrame: 9 months
measure: Height
timeFrame: 9 months
measure: Body Composition - Skinfolds
timeFrame: 9 months
measure: Body Composition - Perimeters
timeFrame: 9 months
measure: Body Composition - Diameters
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alicante
country: Spain
facility: Alejandro Martínez Rodriguez
Study officials:
affiliation: Alicante University
name: Alejandro Martínez Rodríguez
role: PRINCIPAL_INVESTIGATOR
References: