Efficacy of a Natural Ingredient on Blood Pressure (FISTA)

October 3, 2019 updated by: Francisco Javier López Román, Universidad Católica San Antonio de Murcia

Clinical Trial and Randomized Efficacy of a Natural Ingredient on the Arterial Tension of Normother Subjects or With Arterial Hypertension Grade i Without Pharmacological Treatment

Randomized controlled trial with two parallel branches (experimental product and placebo), double blind and unicentric with which it is intended to evaluate the efficacy of the product under investigation against placebo on blood pressure of normotensive subjects or with hypertension grade I without Pharmacotherapy. The subjects that meet the selection criteria will make a total of five visits to the research laboratory and perform the tests that were pre-established in the protocol. Later, a statistical analysis will be carried out with the variables measured in the study to obtain results.

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.

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.
80

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
      • Murcia, Spain, 30107
        • Catholic University of Murcia

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects of both sexes between 18-65 years old.
  • Systolic blood pressure between 120 and 159 mmHg or diastolic blood pressure between 80 and 100 mm Hg. taken in basal conditions.
  • Volunteers able to understand the clinical study and willing to comply with the procedures and requirements of the study

Exclusion Criteria:

  • In pharmacological treatment of arterial hypertension.
  • Subjects with acute diseases.
  • Volunteers with a history or presence of chronic pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunological, dermatological, urological, neurological, psychiatric, cardiovascular or pathological conditions or malignant tumor disease that can modify the blood pressure of subjects.
  • Subjected to major surgery in the last 3 months.
  • Subjects who stopped smoking in the last 6 months or who intend to quit during the study.
  • Subjects with allergies or eating disorders.
  • Participation in another study that includes blood extractions or dietary intervention.
  • Pregnant woman.
  • Subjects whose condition does not make them eligible for the study, according to the researcher.

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: Double

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.
Experimental: Ëxperimental

Consumption during 84 days of Lippia citriodora 325 mg + Hibiscus sabdariffa 175 mg.

Two capsules a day will be consumed thirty minutes before breakfast for 84 days.
Dietary supplement: nutraceutical: experimental product
84 days of consumption
Placebo Comparator: Placebo
Consumption during 84 days of saccharose. Two capsules a day will be consumed thirty minutes before breakfast for 84 days.
Dietary supplement: placebo
84 days of consumption

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
Assessing a change of blood pressure five times
Time Frame: Blood pressure measurements will be taken with a Holter on five separate occasions and for 24 hours each day. The measurements will be made at baseline and at 14, 28, 56 and 84 days of consumption of the product.
blood pressure is measured with a holter
Blood pressure measurements will be taken with a Holter on five separate occasions and for 24 hours each day. The measurements will be made at baseline and at 14, 28, 56 and 84 days of consumption of the product.

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
body composition
Time Frame: Two densitometries will be performed. One at the beginning of the test, in basal conditions and another at the end of the test after 84 days of taking the product.e beginning and at the end
Dual X-ray absorptiometry (DEXA)
Two densitometries will be performed. One at the beginning of the test, in basal conditions and another at the end of the test after 84 days of taking the product.e beginning and at the end
body composition
Time Frame: A record of body composition will be made five times during the 84 days of consumption. Measures will be taken at baseline, at 14 days, 28, 56 and 84 days.
Bioimpedancetry
A record of body composition will be made five times during the 84 days of consumption. Measures will be taken at baseline, at 14 days, 28, 56 and 84 days.
blood samples
Time Frame: Blood samples will be taken twice, once at baseline, at the beginning of the trial and once at the end after 84 days of use.
Glucidal metabolism and lipid metabolism. It was measured in milligrams per deciliter.
Blood samples will be taken twice, once at baseline, at the beginning of the trial and once at the end after 84 days of use.
Subjective sensation of product consumption
Time Frame: Subjects will complete the hedonic scale four times. at 14, 28, 56 and 84 days of consumption of the product under study.
5-point hedonic scale. There are five points, being 1 I do not like and 5 I like it a lot. A scale will be passed through paper.
Subjects will complete the hedonic scale four times. at 14, 28, 56 and 84 days of consumption of the product under study.
physical activity
Time Frame: An accelerometer will be placed twice on the subjects. The first time at baseline and the second after taking 84 days of consumption of the product under study.
accelerometer
An accelerometer will be placed twice on the subjects. The first time at baseline and the second after taking 84 days of consumption of the product under study.
Control of dietary intake
Time Frame: A nutritional registry will be carried out. The nutritional intake of for days in two periods will be collected. One record at the beginning and another at the end, that is, six days.
Diet source
A nutritional registry will be carried out. The nutritional intake of for days in two periods will be collected. One record at the beginning and another at the end, that is, six days.
quality of life questionnaire
Time Frame: The cuestionnaire will be taken twice, once at baseline, at the beginning of the trial and once at the end after 84 days of use. The subjects have to answer 26 items on a scale of one to five, being one never and 5 always.
questionnaire: WHOQOL-BREF
The cuestionnaire will be taken twice, once at baseline, at the beginning of the trial and once at the end after 84 days of use. The subjects have to answer 26 items on a scale of one to five, being one never and 5 always.
Gastrointestinal well-being evaluation
Time Frame: The questionnaire will be completed five times (GIQLI). It will be completed at baseline (without consumption of the product), at 14, 28, 56 and 84 days of consumption of the experimental product.
Gastrointestinal quality of life questionnaire. The subjects have to answer 36 items on a scale of one to five, being 1 all the time and 5 never.
The questionnaire will be completed five times (GIQLI). It will be completed at baseline (without consumption of the product), at 14, 28, 56 and 84 days of consumption of the experimental product.

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 Católica San Antonio de Murcia

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.
April 9, 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.
February 28, 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.
March 30, 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).
February 27, 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.
March 19, 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.
March 20, 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.
October 4, 2019

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.
October 3, 2019

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.
October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

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.
  • UCAM-CFE-0001

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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