NCT06264622UnknownNot Applicable
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
Universitat de Lleida2 sites in 1 country180 target enrollmentStarted: February 26, 2024Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 180
- Locations
- 2
- Primary Endpoint
- Blood Pressure
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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)
Arms & Interventions
Low Dose
Experimental
250 mg/day of Garlic Extract
Intervention: Low dose (Dietary Supplement)
High Dose
Experimental
600 mg/day of Garlic Extract
Intervention: High dose (Dietary Supplement)
Placebo
Placebo Comparator
Placebo tablets
Intervention: Placebo (Dietary Supplement)
Outcomes
Primary Outcomes
Blood Pressure
Time Frame: Pre-treatment and 12 weeks post-treatment
Upper arm blood pressure (Systolic and Diastolic)
Secondary Outcomes
- Blood Lipid Profile(Pre-treatment and 12 weeks post-treatment)
Investigators
José Serrano
Professor
Universitat de Lleida
Study Sites (2)
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