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

NCT06264622 | Recruiting

• 1 other identifier: CEIC-2996
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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

Conditions

Hypertension

Keywords

Grade I Hypertension

Outcome Measures

Primary Outcomes (1)

• Blood Pressure

  Upper arm blood pressure (Systolic and Diastolic)

  Pre-treatment and 12 weeks post-treatment

Secondary Outcomes (1)

• Blood Lipid Profile

  Pre-treatment and 12 weeks post-treatment

Study Arms (3)

Low Dose

EXPERIMENTAL

250 mg/day of Garlic Extract

Dietary Supplement: Low dose

High Dose

EXPERIMENTAL

600 mg/day of Garlic Extract

Dietary Supplement: High dose

Placebo

PLACEBO COMPARATOR

Placebo tablets

Dietary Supplement: Placebo

Interventions

Low dose DIETARY_SUPPLEMENT

2 tablets per day during the morning for 12 weeks.

Low Dose

High dose DIETARY_SUPPLEMENT

2 tablets per day during the morning for 12 weeks.

High Dose

Placebo DIETARY_SUPPLEMENT

2 tablets per day during the morning for 12 weeks.

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitat de Lleida: lead
• Pharmactive Biotech Products S.L.U: collaborator

Study Sites (1)

University of Lleida

Lleida, 25198, Spain

RECRUITING

Related Publications (1)

• 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.

  PMID: 37686723 RESULT

MeSH Terms

Conditions

Hypertension

Interventions

Contraceptives, Oral

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Contraceptive Agents, Female; Contraceptive Agents; Reproductive Control Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 9, 2024
• First Posted: February 20, 2024
• Study Start: February 26, 2024
• Primary Completion: October 31, 2024
• Study Completion: December 31, 2024
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)