Effect of a Black Garlic Extract on Cholesterol LDL Levels

Summary

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.

Conditions

• Cardiovascular Diseases

Interventions

DIETARY_SUPPLEMENT

Aged black garlic extract

Participants will intake a tablet with 250 mg of a aged black garlic extract with higher concentration of bioactive compounds S-allyl cysteine and alliin, and minor unwanted compounds such as simple sugars and furfural derivatives. In addition, during the course of the study, participants will be urged to follow dietary guidelines according to a heart-healthy diet established by nutritionists and that they will adhere to European guidelines for the treatment of dyslipidemias.

DIETARY_SUPPLEMENT

Placebo

Participants will intake a tablet with 250 mg of microcrystalline cellulose. In addition, during the course of the study, participants will be urged to follow dietary guidelines according to a heart-healthy diet established by nutritionists and that they will adhere to European guidelines for the treatment of dyslipidemias.

Sponsors & Collaborators

• Fundació Eurecat

  collaborator OTHER

• Hospital Universitari Sant Joan de Reus

  collaborator OTHER

• University Rovira i Virgili

  collaborator OTHER

• Pharmactive Biotech Products S.L.

  collaborator UNKNOWN

• Technological Centre of Nutrition and Health, Spain

  lead OTHER

Principal Investigators

• Rosa Solà, Dr · Centro Tecnológico de Nutrición y Salud (Eurecat_Reus). Reus, Tarragona, Spain.

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-07-24

Primary Completion

2019-12-19

Completion

2019-12-19

Countries

• Spain

Study Locations