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

NCT ID: NCT06264622

Last Updated: 2024-02-20

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-26

Study Completion Date

2024-12-31

Brief Summary

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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

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Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Low Dose

250 mg/day of Garlic Extract

Group Type EXPERIMENTAL

Low dose

Intervention Type DIETARY_SUPPLEMENT

2 tablets per day during the morning for 12 weeks.

High Dose

600 mg/day of Garlic Extract

Group Type EXPERIMENTAL

High dose

Intervention Type DIETARY_SUPPLEMENT

2 tablets per day during the morning for 12 weeks.

Placebo

Placebo tablets

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

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.

Intervention Type DIETARY_SUPPLEMENT

High dose

2 tablets per day during the morning for 12 weeks.

Intervention Type DIETARY_SUPPLEMENT

Placebo

2 tablets per day during the morning for 12 weeks.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pharmactive Biotech Products S.L.U

INDUSTRY

Sponsor Role collaborator

Universitat de Lleida

OTHER

Sponsor Role lead

Responsible Party

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José Serrano

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Lleida

Lleida, , Spain

Site Status RECRUITING

Countries

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Spain

Facility Contacts

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Jose Serrano, PhD

Role: primary

973702408

Manuel Portero, PhD

Role: backup

973702408

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.

Reference Type RESULT
PMID: 37686723 (View on PubMed)

Other Identifiers

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CEIC-2996

Identifier Type: -

Identifier Source: org_study_id

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