Black Garlic Nutraceuticals and Blood Pressure Control

NCT ID: NCT04915053

Last Updated: 2021-06-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-15

Study Completion Date

2022-06-30

Brief Summary

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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

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Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Three measurements, initial, middle, and final.
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators
Random number of samples

Study Groups

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ABG Black Garlic Extract

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

Group Type EXPERIMENTAL

ABG+ Black Garlin

Intervention Type DIETARY_SUPPLEMENT

Daily tablet intake during three months

Placebo

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

Group Type PLACEBO_COMPARATOR

Crystalline Cellulose

Intervention Type DIETARY_SUPPLEMENT

Daily tablet intake during three months

Interventions

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ABG+ Black Garlin

Daily tablet intake during three months

Intervention Type DIETARY_SUPPLEMENT

Crystalline Cellulose

Daily tablet intake during three months

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pharmactive, S.L.

UNKNOWN

Sponsor Role collaborator

Universitat de Lleida

OTHER

Sponsor Role lead

Responsible Party

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José Serrano

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Manuel S Portero, PhD

Role: PRINCIPAL_INVESTIGATOR

Universitat de Lleida

Locations

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Hospital Arnau de Vilanova

Lleida, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Marcelino Bermúdez, PhD

Role: CONTACT

+34 973702482

Jose S Serrano, PhD

Role: CONTACT

+34 973702408

Facility Contacts

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Macerlino S Bermudez, PhD

Role: primary

+34 973702482

Jose S Serrano Casasola, PhD

Role: backup

+34 973702408

Other Identifiers

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CEIC-2435

Identifier Type: -

Identifier Source: org_study_id

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