ABG+/GarlACE Effects on Cardiovascular Risk Factors in Subjects With Grade I Hypertension

Universitat de Lleida180 enrolled

Overview

The goal of this clinical trial is to evaluate the dose response effect on cardiovascular disease risk factors of a Black Garlic Extract in subjects with Grade I Hypertension. The main questions it aims to answer are: * If the reduction in blood pressure (systolic and diastolic) is in a dose-response manner * If the changes in lipid profile are in a dose-response manner Participants will be randomly assign to a low dose (250 mg/day), high dose (600 mg/day) or placebo of a standardized Garlic Extract (ABG+/GarlACE) during 12 weeks

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

180

Conditions

Hypertension

Interventions

Low doseDIETARY_SUPPLEMENT

2 tablets per day during the morning for 12 weeks.

High doseDIETARY_SUPPLEMENT

2 tablets per day during the morning for 12 weeks.

PlaceboDIETARY_SUPPLEMENT

2 tablets per day during the morning for 12 weeks.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Men and women with Grade I Hypertension (systolic blood pressure between 130 and 139 mmHg; and diastolic blood pressure between 80 to 89 mmHg) without taking any antihypertensive drug Exclusion Criteria: * Acute or chronic kidney disease including dyslipidemia due to nephrotic syndrome.- - * Hypothyroidism * Having previously suffered a myocardial infarction or stroke * Pharmacological treatment with insulin, sulfonylureas, protease inhibitors * Chronic gastrointestinal disease * Pregnancy or intention to become pregnant during the study period. * Breastfeeding * Allergy or intolerance to garlic * High alcohol consumption (\>14 units per week) * Smokers

Locations (1)

University of Lleida

Lleida, Spain

RECRUITING

Outcomes

Primary Outcomes

Blood Pressure

Upper arm blood pressure (Systolic and Diastolic)

Time frame: Pre-treatment and 12 weeks post-treatment

Secondary Outcomes

Blood Lipid Profile

Blood lipid profile including total cholesterol, LDL-cholesterol, HDL-cholesterol and triacylglycerides

Time frame: Pre-treatment and 12 weeks post-treatment

Data from ClinicalTrials.gov

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