Efficacy of a Natural Ingredient on Blood Pressure

NCT03471533 | Completed

• 1 other identifier: UCAM-CFE-0001
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• body composition

  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

  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

  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

  Subjects will complete the hedonic scale four times. at 14, 28, 56 and 84 days of consumption of the product under study.

• physical activity

  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.

Study Arms (2)

Ëxperimental

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: placebo

Interventions

nutraceutical: experimental product DIETARY_SUPPLEMENT

84 days of consumption

Ëxperimental

placebo DIETARY_SUPPLEMENT

84 days of consumption

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Católica San Antonio de Murcia: lead

Study Sites (1)

Catholic University of Murcia

Murcia, 30107, Spain

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized, controlled clinical trial, with two parallel branches, (experimental product and placebo), double blind and unicentric.

Study Record Dates

• First Submitted: February 27, 2018
• First Posted: March 20, 2018
• Study Start: April 9, 2018
• Primary Completion: February 28, 2019
• Study Completion: March 30, 2019
• Last Updated: October 4, 2019

Record last verified: 2019-10

Locations

ES (1)