Black Garlic Nutraceuticals and Blood Pressure Control

NCT04915053 | Unknown DMC

• 1 other identifier: CEIC-2435
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Keywords

Garlic; Nitric oxide; Angiotensin-converting enzyme; Antioxidant capacity; Endothelial function

Outcome Measures

Primary Outcomes (1)

• Change in Blood Pressure

  Indirect measure of blood pressure by a trained physician

  Baseline and 12 weeks

Secondary Outcomes (6)

• Change in Blood nitric oxide content

  Baseline and 12 weeks

• Change in Angiotensin-converting enzyme activity

  Baseline and 12 weeks

• Change in Endothelial function

  Baseline and 12 weeks

• Change in Blood lipid profile

  Baseline and 12 weeks

• Change in Blood cytokine profile

  Baseline and 12 weeks

Study Arms (2)

ABG Black Garlic Extract

EXPERIMENTAL

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

Dietary Supplement: ABG+ Black Garlin

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Crystalline Cellulose

Interventions

ABG+ Black Garlin DIETARY_SUPPLEMENT

Daily tablet intake during three months

ABG Black Garlic Extract

Crystalline Cellulose DIETARY_SUPPLEMENT

Daily tablet intake during three months

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitat de Lleida: lead
• Pharmactive, S.L.: collaborator

Study Sites (1)

Hospital Arnau de Vilanova

Lleida, 25198, Spain

RECRUITING

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Manuel S Portero, PhD

  Universitat de Lleida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marcelino Bermúdez, PhD

CONTACT

+34 973702482; mbermudez@irblleida.cat

Jose S Serrano, PhD

CONTACT

+34 973702408; josecarlos.serrano@udl.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Random number of samples
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Three measurements, initial, middle, and final.

Study Record Dates

• First Submitted: May 24, 2021
• First Posted: June 7, 2021
• Study Start: May 15, 2021
• Primary Completion: December 31, 2021
• Study Completion: June 30, 2022
• Last Updated: June 7, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)