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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06264622
Acronym
GARDOSE
Enrollment
180
Registered
2024-02-20
Start date
2024-02-26
Completion date
2024-12-31
Last updated
2024-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

Grade I Hypertension

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

Interventions

DIETARY_SUPPLEMENTLow dose

2 tablets per day during the morning for 12 weeks.

DIETARY_SUPPLEMENTHigh dose

2 tablets per day during the morning for 12 weeks.

DIETARY_SUPPLEMENTPlacebo

2 tablets per day during the morning for 12 weeks.

Sponsors

Pharmactive Biotech Products S.L.U
CollaboratorINDUSTRY
Universitat de Lleida
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Blood PressurePre-treatment and 12 weeks post-treatmentUpper arm blood pressure (Systolic and Diastolic)

Secondary

MeasureTime frameDescription
Blood Lipid ProfilePre-treatment and 12 weeks post-treatmentBlood lipid profile including total cholesterol, LDL-cholesterol, HDL-cholesterol and triacylglycerides

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026