Efficacy of a Natural Ingredient on Blood Pressure (FISTA)

Universidad Católica San Antonio de Murcia

Status: Completed

Conditions: Hypertension

Treatments: Dietary Supplement: nutraceutical: experimental product; Dietary Supplement: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03471533

UCAM-CFE-0001

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups, including a placebo group

Ëxperimental

Experimental group

Description:

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.

Treatment:

Dietary Supplement: nutraceutical: experimental product

Placebo

Placebo Comparator group

Description:

Consumption during 84 days of saccharose. Two capsules a day will be consumed thirty minutes before breakfast for 84 days.

Treatment:

Dietary Supplement: placebo