NCT04010565: ESACTIVO

Effect of a Black Garlic Extract on Cholesterol LDL Levels

Completed NA Last updated 28 February 2022

What this trial tests

NA trial testing Aged black garlic extract in Cardiovascular Diseases in 67 participants. Completed in 19 December 2019.

Timeline

24 July 2019

Primary endpoint
19 December 2019

19 December 2019

Quick facts

Lead sponsor	Technological Centre of Nutrition and Health, Spain
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	quadruple
Primary purpose	prevention
Enrollment	67
Start date	24 July 2019
Primary completion	19 December 2019
Estimated completion	19 December 2019
Sites	1 location across Spain

Drugs / interventions tested

• Aged black garlic extract
• Placebo

Conditions studied

• Cardiovascular Diseases — all drugs for Cardiovascular Diseases →

Sponsor

Technological Centre of Nutrition and Health, Spain

Who can join

18 and older, any sex, with Cardiovascular Diseases. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

One of the most characteristic components of the Mediterranean diet is garlic (Allium sativum L.), food to which has been attributed protective properties against cardiovascular diseases (CVD). Recently, several methods of garlic processing have been developed to obtain derivatives with milder organoleptic characteristics and a longer shelf life than habitual garlic derivates. One of these strategies is the aging of the garlic by high temperatures treatment that eliminates the taste and characteristic odor of garlic and gives it a dark color, a sweet taste and a slimy texture. Because the changes in the visual and organoleptic characteristics, the garlic obtained by aging at high temperatures is named black garlic.

Interestingly, these modifications translate into an increase in their antioxidant power and their protective capacity against the development of CVDs, mainly due to the formation of melanoidins and to the content of organosulfur derivatives of cysteine compounds, such as S-allyl-cysteine (SAC) and alliin.

Hypothesis of the study: The daily administration of a new extract of aged black garlic (SANE), with a higher concentration of bioactive compounds and lower unwanted compounds will lower cholesterol levels of low density lipoproteins (LDL-c), and will produce favorable changes on other markers of cardiovascular risk in individuals with moderate hypercholesterolemia.

Each 250 mg of SANE contains 0.5% in SAC, which will mean an amount of 1.25 mg of SAC per day, about 5 times more than SAC levels present in many of the black garlic products marketed.

The main objective was to evaluate the effect of the daily intake of a SANE with a higher concentration of bioactive compounds, SAC and alliin, and minor unwanted compounds such as simple sugars and furfural derivatives, in combination with dietary recommendations, on LDL-c levels in individuals with moderate hypercholesterolemia.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Effects of an Optimized Aged Garlic Extract on Cardiovascular Disease Risk Factors in Moderate Hypercholesterolemic Subjects: A Randomized, Crossover, Double-Blind, Sustainedand Controlled Study.
   Valls RM, Companys J, Calderón-Pérez L, Salamanca P, et al · · 2022 · cited 19× · PMID 35276764 · DOI 10.3390/nu14030405