Effect of Hibiscus and Lippia Extract on Blood Pressure

Blood Pressure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03507023
• Other study ID #: UniversidadMHE_Met
• Status: Completed
• Phase: N/A
• Start date: March 26, 2018
• Est. completion date: April 15, 2019

Study information

• Verified date: September 2020
• Source: Universidad Miguel Hernandez de Elche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: April 15, 2019
• Est. primary completion date: April 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Blood Pressure

Intervention

Dietary Supplement:
• Metabolaid®
500 mg per day, in fasting conditions.
• Placebo
500 mg per day, in fasting conditions.

Locations

Country	Name	City	State
Spain	Universidad Miguel Hernandez de Elche	Elche	Alicante

Sponsors (3)

Lead Sponsor	Collaborator
Universidad Miguel Hernandez de Elche	Hospital General Universitario Elche, Monteloeder SL

Country where clinical trial is conducted

Spain, 

Outcome

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