Black Garlic Nutraceuticals and Blood Pressure Control

Not Applicable

• Conditions: Hypertension
• Interventions: Dietary Supplement: ABG+ Black Garlin; Dietary Supplement: Crystalline Cellulose

• Registration Number: NCT04915053
• Lead Sponsor: Universitat de Lleida

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-05
• Study Start: 2021-05-15
• Study First Submitted: 2021-05-24
• Study First Submitted QC: 2021-05-27
• Last Update Submitted: 2021-05-27
• Study First Posted: 2021-06-07
• Last Update Posted: 2021-06-07
• Primary Completion: 2021-12-31
• Study Completion: 2022-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ABG Black Garlic Extract	ABG+ Black Garlin	Daily intake of a 550 mg tablet, containing 250 mg of Black Garlic Extract and 300 mg of excipients.
Placebo	Crystalline Cellulose	Daily intake of a 550 mg tablet, containing 250 mg of microcrystalline cellulose and 300 mg of excipients

Primary Outcome Measures

Name	Time	Method
Change in Blood Pressure	Baseline and 12 weeks	Indirect measure of blood pressure by a trained physician

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hospital Arnau de Vilanova; 🇪🇸 Lleida, Spain