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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
51
500 mg per day, in fasting conditions.
500 mg per day, in fasting conditions.
Universidad Miguel Hernandez de Elche
Elche, Alicante, Spain
Changes in Blood Pressure Measurement with respect to baseline
Using a continuous blood pressure monitor (BPro continuous blood pressure monitor, HealthStats)
Time frame: Continuous measurements for 24 hours, 1 day per week, total 6 weeks
Changes in Blood Pressure Measurement with respect to baseline
Single Blood Pressure measurements, using the Omron M6 Comfort device
Time frame: One measurement per day, 1 day per week, total 6 weeks
Total Cholesterol
Blood Sampling in Fasting conditions, in mg/dl
Time frame: At the beginning and end of the intervention, total 6 weeks
HDL Cholesterol
Blood Sampling in Fasting conditions, in mg/dl
Time frame: At the beginning and end of the intervention, total 6 weeks
LDL Cholesterol
Blood Sampling in Fasting conditions, in mg/dl
Time frame: At the beginning and end of the intervention, total 6 weeks
Triglycerides
Blood Sampling in Fasting conditions, in mg/dl
Time frame: At the beginning and end of the intervention, total 6 weeks
Glucose
Blood Sampling in Fasting conditions, in mg/dl
Time frame: At the beginning and end of the intervention, total 6 weeks
Weight, using a weight scale
In kg
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Time frame: Once a week, for 6 weeks
Height, using measuring tape
in cm
Time frame: Once a week, for 6 weeks
BMI, calculated based on Weight and Height
in kg/m\^2
Time frame: Once a week, for 6 weeks
Waist Circumference, using a measuring tape
in cm
Time frame: Once a week, for 6 weeks
Hip Circumference, using a measuring tape
in cm
Time frame: Once a week, for 6 weeks
Waist/Hip Ratio
Calculated as indicator of obesity, based on Waist and Hip Circumference measurements
Time frame: Once a week, for 6 weeks
Physical Activity Assessment using the Stanford 7-days physical activity recall questionnaire
Subjective assessment of physical activity using a validated questionnaire
Time frame: At baseline, 3 and 6 weeks