Clinical trial NCT03471533: Efficacy of a Natural Ingredient on Blood Pressure
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Lead sponsor: Universidad Católica San Antonio de Murcia
Sponsor class: OTHER
First posted: 2018-03-20
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, controlled clinical trial, with two parallel branches, (experimental product and placebo), double blind and unicentric.
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Assessing a change of blood pressure five times
timeFrame: 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 outcomes:
measure: body composition
timeFrame: 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
measure: body composition
timeFrame: 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.
measure: blood samples
timeFrame: 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.
measure: Subjective sensation of product consumption
timeFrame: Subjects will complete the hedonic scale four times. at 14, 28, 56 and 84 days of consumption of the product under study.
measure: physical activity
timeFrame: 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.
measure: Control of dietary intake
timeFrame: 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.
measure: quality of life questionnaire
timeFrame: 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.
measure: Gastrointestinal well-being evaluation
timeFrame: 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.
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Catholic University of Murcia
Study officials:
References: