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

Universitat de Lleida

Status: Enrolling

Conditions: Hypertension

Treatments: Dietary Supplement: Low dose; Dietary Supplement: Placebo; Dietary Supplement: High dose

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06264622

CEIC-2996

Details and patient eligibility

About

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

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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180 participants in 3 patient groups, including a placebo group

Low Dose

Experimental group

Description:

250 mg/day of Garlic Extract

Treatment:

Dietary Supplement: Low dose

High Dose

Experimental group

Description:

600 mg/day of Garlic Extract

Treatment:

Dietary Supplement: High dose

Placebo

Placebo Comparator group

Description:

Placebo tablets

Treatment:

Dietary Supplement: Placebo