Effect of Hibiscus and Lippia Extract on Blood Pressure

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of the Combination of Polyphenols Derived From the Hibiscus Sabdariffa and Lippia Citriodora on Slightly Hypertensive or Type 1 Hypertensive Volunteers

Conditions
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Blood Pressure

Intervention / Treatment
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* Dietary Supplement: Metabolaid®
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo Control<br>2 capsules per day, each with 400 mg Cellulose microcrystalline, for 6 weeks. | Dietary Supplement: Placebo<br>* 500 mg per day, in fasting conditions.<br>|
| Experimental: Dietetic Supplement Group<br>2 Capsules per day of Metabolaid® (each capsule contains 250 mg Metabolaid®, 150 mg cellulose microcrystalline), for 6 weeks. | Dietary Supplement: Metabolaid®<br>* 500 mg per day, in fasting conditions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Blood Pressure Measurement with respect to baseline | Using a continuous blood pressure monitor (BPro continuous blood pressure monitor, HealthStats) | 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 | One measurement per day, 1 day per week, total 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Cholesterol | Blood Sampling in Fasting conditions, in mg/dl | At the beginning and end of the intervention, total 6 weeks | 
| HDL Cholesterol | Blood Sampling in Fasting conditions, in mg/dl | At the beginning and end of the intervention, total 6 weeks | 
| LDL Cholesterol | Blood Sampling in Fasting conditions, in mg/dl | At the beginning and end of the intervention, total 6 weeks | 
| Triglycerides | Blood Sampling in Fasting conditions, in mg/dl | At the beginning and end of the intervention, total 6 weeks | 
| Glucose | Blood Sampling in Fasting conditions, in mg/dl | At the beginning and end of the intervention, total 6 weeks | 
| Weight, using a weight scale | In kg | Once a week, for 6 weeks | 
| Height, using measuring tape | in cm | Once a week, for 6 weeks | 
| BMI, calculated based on Weight and Height | in kg/m^2 | Once a week, for 6 weeks | 
| Waist Circumference, using a measuring tape | in cm | Once a week, for 6 weeks | 
| Hip Circumference, using a measuring tape | in cm | Once a week, for 6 weeks | 
| Waist/Hip Ratio | Calculated as indicator of obesity, based on Waist and Hip Circumference measurements | 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 | At baseline, 3 and 6 weeks |