Black Garlic Nutraceuticals and Blood Pressure Control (ENDOGARLIC)

Universitat de Lleida

Status: Unknown

Conditions: Hypertension

Treatments: Dietary Supplement: Crystalline Cellulose; Dietary Supplement: ABG+ Black Garlin

Study type: Interventional

Funder types: Other

Identifiers

NCT04915053

CEIC-2435

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups, including a placebo group

ABG Black Garlic Extract

Experimental group

Description:

Daily intake of a 550 mg tablet, containing 250 mg of Black Garlic Extract and 300 mg of excipients.

Treatment:

Dietary Supplement: ABG+ Black Garlin

Placebo

Placebo Comparator group

Description:

Daily intake of a 550 mg tablet, containing 250 mg of microcrystalline cellulose and 300 mg of excipients

Treatment:

Dietary Supplement: Crystalline Cellulose