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

Not Applicable

Recruiting

• Conditions: Hypertension
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Low dose; Dietary Supplement: High dose

• Registration Number: NCT06264622
• Lead Sponsor: Universitat de Lleida

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-02
• Study First Submitted: 2024-02-09
• Study First Submitted QC: 2024-02-09
• Last Update Submitted: 2024-02-09
• Study First Posted: 2024-02-20
• Last Update Posted: 2024-02-20
• Study Start: 2024-02-26
• Primary Completion: 2024-10-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 180

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo tablets
Low Dose	Low dose	250 mg/day of Garlic Extract
High Dose	High dose	600 mg/day of Garlic Extract

Primary Outcome Measures

Name	Time	Method
Blood Pressure	Pre-treatment and 12 weeks post-treatment	Upper arm blood pressure (Systolic and Diastolic)

Secondary Outcome Measures

Name	Time	Method
Blood Lipid Profile	Pre-treatment and 12 weeks post-treatment	Blood lipid profile including total cholesterol, LDL-cholesterol, HDL-cholesterol and triacylglycerides

Trial Locations

Locations (1)

University of Lleida; 🇪🇸 Lleida, Spain