Effect of Hibiscus and Lippia Extract on Blood Pressure

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

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.

Study Overview

• Status: Completed
• Conditions: Blood Pressure
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Metabolaid®

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.

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Alicante
    • Elche, Alicante, Spain, 03202
      • Universidad Miguel Hernandez de Elche

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Universidad Miguel Hernandez de Elche
• Collaborators: Hospital General Universitario Elche; Monteloeder SL

Study record dates

Study Major Dates

• Study Start (Actual): March 26, 2018
• Primary Completion (Actual): April 1, 2019
• Study Completion (Actual): April 15, 2019

Study Registration Dates

• First Submitted: March 16, 2018
• First Submitted That Met QC Criteria: April 13, 2018
• First Posted (Actual): April 24, 2018

Study Record Updates

• Last Update Posted (Actual): September 4, 2020
• Last Update Submitted That Met QC Criteria: September 3, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: UniversidadMHE_Met

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No