Effect of Hibiscus and Lippia Extract on Blood Pressure

September 3, 2020 updated by: María Herranz-Lopez, Universidad Miguel Hernandez de Elche

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
51

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 61 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes in Blood Pressure Measurement with respect to baseline
Time Frame: Continuous measurements for 24 hours, 1 day per week, total 6 weeks
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
Time Frame: One measurement per day, 1 day per week, total 6 weeks
Single Blood Pressure measurements, using the Omron M6 Comfort device
One measurement per day, 1 day per week, total 6 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Total Cholesterol
Time Frame: At the beginning and end of the intervention, total 6 weeks
Blood Sampling in Fasting conditions, in mg/dl
At the beginning and end of the intervention, total 6 weeks
HDL Cholesterol
Time Frame: At the beginning and end of the intervention, total 6 weeks
Blood Sampling in Fasting conditions, in mg/dl
At the beginning and end of the intervention, total 6 weeks
LDL Cholesterol
Time Frame: At the beginning and end of the intervention, total 6 weeks
Blood Sampling in Fasting conditions, in mg/dl
At the beginning and end of the intervention, total 6 weeks
Triglycerides
Time Frame: At the beginning and end of the intervention, total 6 weeks
Blood Sampling in Fasting conditions, in mg/dl
At the beginning and end of the intervention, total 6 weeks
Glucose
Time Frame: At the beginning and end of the intervention, total 6 weeks
Blood Sampling in Fasting conditions, in mg/dl
At the beginning and end of the intervention, total 6 weeks
Weight, using a weight scale
Time Frame: Once a week, for 6 weeks
In kg
Once a week, for 6 weeks
Height, using measuring tape
Time Frame: Once a week, for 6 weeks
in cm
Once a week, for 6 weeks
BMI, calculated based on Weight and Height
Time Frame: Once a week, for 6 weeks
in kg/m^2
Once a week, for 6 weeks
Waist Circumference, using a measuring tape
Time Frame: Once a week, for 6 weeks
in cm
Once a week, for 6 weeks
Hip Circumference, using a measuring tape
Time Frame: Once a week, for 6 weeks
in cm
Once a week, for 6 weeks
Waist/Hip Ratio
Time Frame: Once a week, for 6 weeks
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
Time Frame: At baseline, 3 and 6 weeks
Subjective assessment of physical activity using a validated questionnaire
At baseline, 3 and 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidad Miguel Hernandez de Elche

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Hospital General Universitario Elche
Monteloeder SL

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 26, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 15, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 16, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 13, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 24, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 4, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 3, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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