Efficacy of a Natural Ingredient on Blood Pressure (FISTA)

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: Completed
• Conditions: Hypertension
• Intervention / Treatment: Dietary supplement: nutraceutical: experimental product; Dietary supplement: placebo

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Murcia, Spain, 30107
    • Catholic University of Murcia

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Assessing a change of blood pressure five times	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

Outcome Measure	Measure Description	Time Frame
body composition	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	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	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	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	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	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	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	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

• Sponsor: Universidad Católica San Antonio de Murcia

Study record dates

Study Major Dates

• Study Start (Actual): April 9, 2018
• Primary Completion (Actual): February 28, 2019
• Study Completion (Actual): March 30, 2019

Study Registration Dates

• First Submitted: February 27, 2018
• First Submitted That Met QC Criteria: March 19, 2018
• First Posted (Actual): March 20, 2018

Study Record Updates

• Last Update Posted (Actual): October 4, 2019
• Last Update Submitted That Met QC Criteria: October 3, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID 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