Black Garlic Nutraceuticals and Blood Pressure Control (ENDOGARLIC)

Black Garlic Nutraceuticals Supplementation for the Control of Blood Pressure in Hypertension. A Triple-blind Randomized Placebo Control Study.

Black garlic contains a series of allyl-sulfur compounds with the ability to modulate nitric oxide synthetase, angiotensin-converting enzyme system, and endothelial activation, which together could help better control blood pressure. The main objective of this study is to evaluate the effect on blood pressure and endothelial health of a daily intake of a black garlic supplement named ABG (registered mark), which has a higher concentration of black garlic bioactive compounds, in people with moderate hypertension.

Study Overview

• Status: Recruiting
• Conditions: Hypertension
• Intervention / Treatment: Dietary supplement: ABG+ Black Garlin; Dietary supplement: Crystalline Cellulose

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marcelino Bermúdez, PhD; Phone Number: +34 973702482; Email: mbermudez@irblleida.cat
• Study Contact Backup: Name: Jose S Serrano, PhD; Phone Number: +34 973702408; Email: josecarlos.serrano@udl.cat

Study Locations

• Spain
  • Lleida, Spain, 25198
    • Recruiting
    • Hospital Arnau de Vilanova
    • Contact: Macerlino S Bermudez, PhD; Phone Number: +34 973702482; Email: mbermudez@irblleida.cat
    • Contact: Jose S Serrano Casasola, PhD; Phone Number: +34 973702408; Email: josecarlos.serrano@udl.cat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

- Clinical hypertension, medically treated with no more than 2 drugs

Exclusion Criteria:

• Body mass index above 35 kg/m2
• Fasting blood cholesterol levels below 115 mg/dL
• Fasting blood glucose levels above 126 mg/dL
• Taking anyone of the Angiotensin-converting enzyme inhibitors
• Anemia (hemoglobin below 13 g/dL in men and below 12 g/dL in women)
• Vitamin or nutraceutical intake in the last 30 days before the study enrollment
• Chronic gastrointestinal diseases
• Pregnancy and breastfeeding
• Garlic allergy
• Participation in another study 30 days before the study enrollment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: ABG Black Garlic Extract; Daily intake of a 550 mg tablet, containing 250 mg of Black Garlic Extract and 300 mg of excipients.	Dietary supplement: ABG+ Black Garlin; Daily tablet intake during three months
PLACEBO_COMPARATOR: Placebo; Daily intake of a 550 mg tablet, containing 250 mg of microcrystalline cellulose and 300 mg of excipients	Dietary supplement: Crystalline Cellulose; Daily tablet intake during three months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Blood Pressure	Indirect measure of blood pressure by a trained physician	Baseline and 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Blood nitric oxide content	Nitric oxide determined by nitrate and nitrite content in blood	Baseline and 12 weeks
Change in Angiotensin-converting enzyme activity	Activity measured by a substrate-enzyme activity kit	Baseline and 12 weeks
Change in Endothelial function	Endothelial blood flow capacity	Baseline and 12 weeks
Change in Blood lipid profile	Analysis of lipid profile (Total-cholesterol, LDL-cholesterol, Triacylglycerides, HDL-Cholesterol)	Baseline and 12 weeks
Change in Blood cytokine profile	Analysis of cytokine profile (TNFa, IL-1b, IL-18, IL-6, IL-8, IL-17, IL-23, TGFb) in blood by immunoassays (Multiplexed)	Baseline and 12 weeks
Change in Blood antioxidant capacity	Reduction capacity of blood determined by a biochemistry assay	Baseline and 12 weeks

Collaborators and Investigators

• Sponsor: Universitat de Lleida
• Collaborators: Pharmactive, S.L.
• Investigators: Principal Investigator: Manuel S Portero, PhD, Universitat de Lleida

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 15, 2021
• Primary Completion (ANTICIPATED): December 31, 2021
• Study Completion (ANTICIPATED): June 30, 2022

Study Registration Dates

• First Submitted: May 24, 2021
• First Submitted That Met QC Criteria: May 27, 2021
• First Posted (ACTUAL): June 7, 2021

Study Record Updates

• Last Update Posted (ACTUAL): June 7, 2021
• Last Update Submitted That Met QC Criteria: May 27, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Garlic; Endothelial function; Nitric oxide; Antioxidant capacity; Angiotensin-converting enzyme
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: CEIC-2435

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD data will not be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No