Effect of Hibiscus and Lippia Extract on Blood Pressure

Miguel Hernández University of Elche

Status: Completed

Conditions: Blood Pressure

Treatments: Dietary Supplement: Metabolaid®; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03507023

UniversidadMHE_Met

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 51 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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51 participants in 2 patient groups, including a placebo group

Placebo Control

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo

Dietetic Supplement Group

Experimental group

Description:

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

Treatment:

Dietary Supplement: Metabolaid®