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

February 9, 2024 updated by: José Serrano, Universitat de Lleida

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

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo tablets
Dietary supplement: Placebo
2 tablets per day during the morning for 12 weeks.
Experimental: Low Dose
250 mg/day of Garlic Extract
Dietary supplement: Low dose
2 tablets per day during the morning for 12 weeks.
Experimental: High Dose
600 mg/day of Garlic Extract
Dietary supplement: High dose
2 tablets per day during the morning for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood Pressure
Time Frame: Pre-treatment and 12 weeks post-treatment
Upper arm blood pressure (Systolic and Diastolic)
Pre-treatment and 12 weeks post-treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood Lipid Profile
Time Frame: Pre-treatment and 12 weeks post-treatment
Blood lipid profile including total cholesterol, LDL-cholesterol, HDL-cholesterol and triacylglycerides
Pre-treatment and 12 weeks post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitat de Lleida

Collaborators

Pharmactive Biotech Products S.L.U

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 26, 2024

Primary Completion (Estimated)

October 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

February 9, 2024

First Submitted That Met QC Criteria

February 9, 2024

First Posted (Actual)

February 20, 2024

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 9, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEIC-2996

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No individual participant data will be available to other researchers. Group data could be asked by demand

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hypertension

Clinical Trials on Low dose

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Dominican Republic

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe