ABG+/GarlACE Effects on Cardiovascular Risk Factors in Subjects With Grade I Hypertension
NCT ID: NCT06264622
Last Updated: 2024-02-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
180 participants
INTERVENTIONAL
2024-02-26
2024-12-31
Brief Summary
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* 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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Low Dose
250 mg/day of Garlic Extract
Low dose
2 tablets per day during the morning for 12 weeks.
High Dose
600 mg/day of Garlic Extract
High dose
2 tablets per day during the morning for 12 weeks.
Placebo
Placebo tablets
Placebo
2 tablets per day during the morning for 12 weeks.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
75 Years
ALL
Yes
Sponsors
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Pharmactive Biotech Products S.L.U
INDUSTRY
Universitat de Lleida
OTHER
Responsible Party
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José Serrano
Professor
Locations
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University of Lleida
Lleida, , Spain
Countries
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Facility Contacts
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References
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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 Antihypertensive Drug Therapy: A Randomized, Triple-Blind Controlled Trial. Nutrients. 2023 Aug 23;15(17):3691. doi: 10.3390/nu15173691.
Other Identifiers
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CEIC-2996
Identifier Type: -
Identifier Source: org_study_id
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