Blood Pressure
Conditions
Brief summary
Determine if a double-blind, randomized, placebo-controlled clinical intervention, based on a dietetic intervention and physical exercise, supplemented with a polyphenolic extract, decreases blood pressure in hypertensive volunteers.
Detailed description
Slightly hypertensive individuals, before diagnosed with type 1 hypertension, are generally monitored by their physician and given dietetic and physical activity guidelines. The objective of this intervention is to prevent onset of a hypertensive pathologic condition. However, in many cases, this intervention is unsuccessful, and therefore the patient must follow-up with anti-hypertensive drugs. Here, in the current study, the objective is to include a nutritional supplement in the intervention in order to increase the probability of success of the diet/exercise intervention. Previous studies with the supplement Metabolaid has shown the product to significantly decrease the blood pressure of slightly hypertensive individuals. It is estimated, based on the results of previous clinical studies, that the polyphenolic content of the nutritional supplement will reduce at least an additional 10% of the blood pressure of the patients undergoing a diet and exercise intervention.
Interventions
DIETARY_SUPPLEMENTMetabolaid®
500 mg per day, in fasting conditions.
DIETARY_SUPPLEMENTPlacebo
500 mg per day, in fasting conditions.
Sponsors
Hospital General Universitario Elche
Monteloeder SL
Universidad Miguel Hernandez de Elche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Slight or type 1 hypertension with no pharmacological treatment, but with annual controls of the blood pressure
Exclusion criteria
* Minors (under 18 years of age) * volunteers with high cardiovascular disease risk * pharmacological treatment for blood pressure * presence of any chronic disease/condition * known allergies regarding the supplement and/or placebo
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Blood Pressure Measurement with respect to baseline | Continuous measurements for 24 hours, 1 day per week, total 6 weeks | Using a continuous blood pressure monitor (BPro continuous blood pressure monitor, HealthStats) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HDL Cholesterol | At the beginning and end of the intervention, total 6 weeks | Blood Sampling in Fasting conditions, in mg/dl |
| LDL Cholesterol | At the beginning and end of the intervention, total 6 weeks | Blood Sampling in Fasting conditions, in mg/dl |
| Triglycerides | At the beginning and end of the intervention, total 6 weeks | Blood Sampling in Fasting conditions, in mg/dl |
| Glucose | At the beginning and end of the intervention, total 6 weeks | Blood Sampling in Fasting conditions, in mg/dl |
| Weight, using a weight scale | Once a week, for 6 weeks | In kg |
| Total Cholesterol | At the beginning and end of the intervention, total 6 weeks | Blood Sampling in Fasting conditions, in mg/dl |
| BMI, calculated based on Weight and Height | Once a week, for 6 weeks | in kg/m\^2 |
| Waist Circumference, using a measuring tape | Once a week, for 6 weeks | in cm |
| Hip Circumference, using a measuring tape | Once a week, for 6 weeks | in cm |
| Waist/Hip Ratio | Once a week, for 6 weeks | Calculated as indicator of obesity, based on Waist and Hip Circumference measurements |
| Physical Activity Assessment using the Stanford 7-days physical activity recall questionnaire | At baseline, 3 and 6 weeks | Subjective assessment of physical activity using a validated questionnaire |
| Height, using measuring tape | Once a week, for 6 weeks | in cm |
Countries
Spain
Outcome results
None listed