Effect of Hibiscus and Lippia Extract on Blood Pressure
- Conditions
- Blood Pressure
- Interventions
- Dietary Supplement: Metabolaid®Dietary Supplement: Placebo
- Registration Number
- NCT03507023
- Lead Sponsor
- Universidad Miguel Hernandez de Elche
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 51
- Slight or type 1 hypertension with no pharmacological treatment, but with annual controls of the blood pressure
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dietetic Supplement Group Metabolaid® 2 Capsules per day of Metabolaid® (each capsule contains 250 mg Metabolaid®, 150 mg cellulose microcrystalline), for 6 weeks. Placebo Control Placebo 2 capsules per day, each with 400 mg Cellulose microcrystalline, for 6 weeks.
- Primary Outcome Measures
Name Time Method Changes in Blood Pressure Measurement with respect to baseline One measurement per day, 1 day per week, total 6 weeks Single Blood Pressure measurements, using the Omron M6 Comfort device
- Secondary Outcome Measures
Name Time Method Total Cholesterol At the beginning and end of the intervention, total 6 weeks Blood Sampling in Fasting conditions, in mg/dl
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
Height, using measuring tape Once a week, for 6 weeks in cm
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
Trial Locations
- Locations (1)
Universidad Miguel Hernandez de Elche
🇪🇸Elche, Alicante, Spain