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

Hypertension Clinical Trial

— GARDOSE  

Official title:

Dose Response Study of the Effects of a Daily Supplementation With a Black Garlic Extract, ABG+/GarlACE on Cardiovascular Disease Risk Factors in Subjects With Grade I Hypertension

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06264622
• Other study ID #: CEIC-2996
• Status: Recruiting
• Phase: N/A
• Start date: February 26, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: Universitat de Lleida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: December 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension

Intervention

Dietary Supplement:
• Low dose
2 tablets per day during the morning for 12 weeks.
• High dose
2 tablets per day during the morning for 12 weeks.
• Placebo
2 tablets per day during the morning for 12 weeks.

Locations

Country	Name	City	State
Spain	University of Lleida	Lleida

Sponsors (2)

Lead Sponsor	Collaborator
Universitat de Lleida	Pharmactive Biotech Products S.L.U

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Serrano JCE, Castro-Boque E, Garcia-Carrasco A, Moran-Valero MI, Gonzalez-Hedstrom D, Bermudez-Lopez M, Valdivielso JM, Espinel AE, Portero-Otin M. Antihypertensive Effects of an Optimized Aged Garlic Extract in Subjects with Grade I Hypertension and Anti — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Pressure	Upper arm blood pressure (Systolic and Diastolic)	Pre-treatment and 12 weeks post-treatment
Secondary	Blood Lipid Profile	Blood lipid profile including total cholesterol, LDL-cholesterol, HDL-cholesterol and triacylglycerides	Pre-treatment and 12 weeks post-treatment