Effect of the Combination of Polyphenols Derived From the Hibiscus Sabdariffa and Lippia Citriodora on Slightly Hypertensive or Type 1 Hypertensive Volunteers
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Blood Pressure
- Sponsor
- Universidad Miguel Hernandez de Elche
- Enrollment
- 51
- Locations
- 1
- Primary Endpoint
- Changes in Blood Pressure Measurement with respect to baseline
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
María Herranz-Lopez
Assistant Professor
Universidad Miguel Hernandez de Elche
Eligibility Criteria
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
Outcomes
Primary Outcomes
Changes in Blood Pressure Measurement with respect to baseline
Time Frame: One measurement per day, 1 day per week, total 6 weeks
Single Blood Pressure measurements, using the Omron M6 Comfort device
Secondary Outcomes
- Total Cholesterol(At the beginning and end of the intervention, total 6 weeks)
- HDL Cholesterol(At the beginning and end of the intervention, total 6 weeks)
- LDL Cholesterol(At the beginning and end of the intervention, total 6 weeks)
- Triglycerides(At the beginning and end of the intervention, total 6 weeks)
- Glucose(At the beginning and end of the intervention, total 6 weeks)
- Weight, using a weight scale(Once a week, for 6 weeks)
- Height, using measuring tape(Once a week, for 6 weeks)
- BMI, calculated based on Weight and Height(Once a week, for 6 weeks)
- Waist Circumference, using a measuring tape(Once a week, for 6 weeks)
- Hip Circumference, using a measuring tape(Once a week, for 6 weeks)
- Waist/Hip Ratio(Once a week, for 6 weeks)
- Physical Activity Assessment using the Stanford 7-days physical activity recall questionnaire(At baseline, 3 and 6 weeks)