Effect of Hibiscus and Lippia Extract on Blood Pressure

NCT ID: NCT03507023

Last Updated: 2020-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-26

Study Completion Date

2019-04-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Determine if a double-blind, randomized, placebo-controlled clinical intervention, based on a dietetic intervention and physical exercise, supplemented with a polyphenolic extract, decreases blood pressure in hypertensive volunteers.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Slightly hypertensive individuals, before diagnosed with type 1 hypertension, are generally monitored by their physician and given dietetic and physical activity guidelines. The objective of this intervention is to prevent onset of a hypertensive pathologic condition. However, in many cases, this intervention is unsuccessful, and therefore the patient must follow-up with anti-hypertensive drugs.

Here, in the current study, the objective is to include a nutritional supplement in the intervention in order to increase the probability of success of the diet/exercise intervention. Previous studies with the supplement Metabolaid has shown the product to significantly decrease the blood pressure of slightly hypertensive individuals. It is estimated, based on the results of previous clinical studies, that the polyphenolic content of the nutritional supplement will reduce at least an additional 10% of the blood pressure of the patients undergoing a diet and exercise intervention.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Blood Pressure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Placebo Control

2 capsules per day, each with 400 mg Cellulose microcrystalline, for 6 weeks.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

500 mg per day, in fasting conditions.

Dietetic Supplement Group

2 Capsules per day of Metabolaid® (each capsule contains 250 mg Metabolaid®, 150 mg cellulose microcrystalline), for 6 weeks.

Group Type EXPERIMENTAL

Metabolaid®

Intervention Type DIETARY_SUPPLEMENT

500 mg per day, in fasting conditions.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Metabolaid®

500 mg per day, in fasting conditions.

Intervention Type DIETARY_SUPPLEMENT

Placebo

500 mg per day, in fasting conditions.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Slight or type 1 hypertension with no pharmacological treatment, but with annual controls of the blood pressure

Exclusion Criteria

* Minors (under 18 years of age)
* volunteers with high cardiovascular disease risk
* pharmacological treatment for blood pressure
* presence of any chronic disease/condition
* known allergies regarding the supplement and/or placebo
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hospital General Universitario Elche

OTHER

Sponsor Role collaborator

Monteloeder SL

UNKNOWN

Sponsor Role collaborator

Universidad Miguel Hernandez de Elche

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

María Herranz-Lopez

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Universidad Miguel Hernandez de Elche

Elche, Alicante, Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Spain

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

UniversidadMHE_Met

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Herbal Extract Study
NCT02095301 COMPLETED NA