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OpenTrials
Completed

NCT Number: NCT03471533

Efficacy of a Natural Ingredient on Blood Pressure

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Catholic University of Murcia

Murcia, 30107, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

nutraceutical: experimental product

Dietary Supplement

84 days of consumption

Placebo

Dietary Supplement

84 days of consumption

Primary outcomes

  1. 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

Secondary outcomes

  1. 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)

  2. 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

  3. 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.

  4. 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.

  5. 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

  6. 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

  7. 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

  8. 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.

Sponsors and collaborators

Lead sponsor

Universidad Católica San Antonio de Murcia

Other

Registry information

Official study 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

Acronym: FISTA

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 20, 2018
Registry last updated
Oct 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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