Black Garlic Nutraceuticals and Blood Pressure Control

Hypertension Clinical Trial

— ENDOGARLIC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04915053
• Other study ID #: CEIC-2435
• Status: Recruiting
• Phase: N/A
• Start date: May 15, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: May 2021
• Source: Universitat de Lleida
• Contact: Marcelino Bermúdez, PhD
• Phone: +34 973702482
• Email: mbermudez[@]irblleida.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 30, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension

Intervention

Dietary Supplement:
• ABG+ Black Garlin
Daily tablet intake during three months
• Crystalline Cellulose
Daily tablet intake during three months

Locations

Country	Name	City	State
Spain	Hospital Arnau de Vilanova	Lleida

Sponsors (2)

Lead Sponsor	Collaborator
Universitat de Lleida	Pharmactive, S.L.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Blood Pressure	Indirect measure of blood pressure by a trained physician	Baseline and 12 weeks
Secondary	Change in Blood nitric oxide content	Nitric oxide determined by nitrate and nitrite content in blood	Baseline and 12 weeks
Secondary	Change in Angiotensin-converting enzyme activity	Activity measured by a substrate-enzyme activity kit	Baseline and 12 weeks
Secondary	Change in Endothelial function	Endothelial blood flow capacity	Baseline and 12 weeks
Secondary	Change in Blood lipid profile	Analysis of lipid profile (Total-cholesterol, LDL-cholesterol, Triacylglycerides, HDL-Cholesterol)	Baseline and 12 weeks
Secondary	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
Secondary	Change in Blood antioxidant capacity	Reduction capacity of blood determined by a biochemistry assay	Baseline and 12 weeks