Efficacy of a Natural Ingredient on Blood Pressure

NCT ID: NCT03471533

Last Updated: 2019-10-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-09
• Study Completion Date: 2019-03-30

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.

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

nutraceutical: experimental product

Intervention Type: DIETARY_SUPPLEMENT

84 days of consumption

Placebo

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

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DIETARY_SUPPLEMENT

84 days of consumption

Interventions

nutraceutical: experimental product

84 days of consumption

Intervention Type: DIETARY_SUPPLEMENT

placebo

84 days of consumption

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universidad Católica San Antonio de Murcia

OTHER

Sponsor Role: lead

Responsible Party

Francisco Javier López Román

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Catholic University of Murcia

Murcia, , Spain

Countries

Spain

Other Identifiers

UCAM-CFE-0001

Identifier Type: -

Identifier Source: org_study_id