Clinical trial NCT03507023: Effect of Hibiscus and Lippia Extract on Blood Pressure
Official title: Effect of the Combination of Polyphenols Derived From the Hibiscus Sabdariffa and Lippia Citriodora on Slightly Hypertensive or Type 1 Hypertensive Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Pressure
Lead sponsor: Universidad Miguel Hernandez de Elche
Sponsor class: OTHER
Collaborators: name: Hospital General Universitario Elche
name: Monteloeder SL
First posted: 2018-04-24
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Changes in Blood Pressure Measurement with respect to baseline
timeFrame: Continuous measurements for 24 hours, 1 day per week, total 6 weeks
measure: Changes in Blood Pressure Measurement with respect to baseline
timeFrame: One measurement per day, 1 day per week, total 6 weeks
Secondary outcomes:
measure: Total Cholesterol
timeFrame: At the beginning and end of the intervention, total 6 weeks
measure: HDL Cholesterol
timeFrame: At the beginning and end of the intervention, total 6 weeks
measure: LDL Cholesterol
timeFrame: At the beginning and end of the intervention, total 6 weeks
measure: Triglycerides
timeFrame: At the beginning and end of the intervention, total 6 weeks
measure: Glucose
timeFrame: At the beginning and end of the intervention, total 6 weeks
measure: Weight, using a weight scale
timeFrame: Once a week, for 6 weeks
measure: Height, using measuring tape
timeFrame: Once a week, for 6 weeks
measure: BMI, calculated based on Weight and Height
timeFrame: Once a week, for 6 weeks
measure: Waist Circumference, using a measuring tape
timeFrame: Once a week, for 6 weeks
measure: Hip Circumference, using a measuring tape
timeFrame: Once a week, for 6 weeks
measure: Waist/Hip Ratio
timeFrame: Once a week, for 6 weeks
measure: Physical Activity Assessment using the Stanford 7-days physical activity recall questionnaire
timeFrame: At baseline, 3 and 6 weeks
Other outcomes:
Locations:
city: Elche
country: Spain
facility: Universidad Miguel Hernandez de Elche
state: Alicante
Study officials:
References: