Effect of a Black Garlic Extract on Cholesterol LDL Levels

NCT04010565 | Completed

• 1 other identifier: ESACTIVO
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Cholesterol LDL; Black garlic extract; S-allyl cysteine

Outcome Measures

Primary Outcomes (1)

• LDL-c levels

  Serum LDL-c levels will be measured by standardized methods in Cobas Mira Plus autoanalyzer (Roche Diagnostics Systems, Madrid, Spain).

  At week 1, week 3 and week 6 for each of the two treatments (SANE and placebo).

Secondary Outcomes (8)

• Measures of body weight

  At week 1, week 3 and week 6 for each of the two treatments (SANE and placebo).

• Measures of height

  At week 1, week 3 and week 6 for each of the two treatments (SANE and placebo).

• Measures of BMI

  At week 1 for each of the two treatments (SANE and placebo).

• Measures of waist circumference

  At week 1, week 3 and week 6 for each of the two treatments (SANE and placebo).

• Bood pressure (measured in mmHg)

  At week 1, week 3 and week 6 for each of the two treatments (SANE and placebo).

Study Arms (2)

Extract of aged black garlic

EXPERIMENTAL

Participants will consume a tablet of 550 mg daily with 250 mg of aged black garlic extract and 300 mg of excipients (microcrystaline cellulose 90 mg; dicalcium phosphate 157 mg; crosscamellose sodium 10 mg; magnesium stearate 7 mg; sodium alignate 3.06 mg; stearic acid 0.03 mg; oleic acid 1.54 mg; medium chain triglycerides 2.80 mg; ethylcellulose 13.17 mg; hydroxypropylcellulose 4.86 mg; hydroxypropylmethylcellulose 4.86 mg; talcum 2.88 mg; titanium dioxide 1.80 mg; vanilla aroma 1.00 mg) .

Dietary Supplement: Aged black garlic extract

Placebo

PLACEBO COMPARATOR

Participants will consume a tablet of 550 mg daily with 550 mg of excipients (microcrystaline cellulose 342.5 mg; dicalcium phosphate 154.5 mg; crosscamellose sodium 10 mg; magnesium stearate 7 mg; sodium alignate 3.06 mg; stearic acid 0.03 mg; oleic acid 1.54 mg; medium chain triglycerides 2.80 mg; ethylcellulose 13.17 mg; hydroxypropylcellulose 4.86 mg; hydroxypropylmethylcellulose 4.86 mg; talcum 2.88 mg; titanium dioxide 1.80 mg; vanilla aroma 1.00 mg).

Dietary Supplement: Placebo

Interventions

Aged black garlic extract DIETARY_SUPPLEMENT

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.

Extract of aged black garlic

Placebo DIETARY_SUPPLEMENT

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.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women over 18 years of age.
• Fasting serum LDL-c concentration ≥ 115 mg/dL.
• Sign the informed consent.

You may not qualify if:

• BMI ≥ 35 kg/m\^2
• LDL-c serum levels \<115 mg/dL
• Serum glucose levels higher than 126 mg/dL
• Take supplements or multivitamin supplements or phytotherapeutic products that interfere with the treatment under study up to 30 days before the start of the study.
• Be a smoker
• Follow a hypocaloric diet and/or pharmacological treatment for weight loss.
• Anti-hypertensive treatment.
• Presenting anemia (hemoglobin ≤ 13 g/dL in men and ≤ 12 g/dL in women).
• Present some chronic gastrointestinal disease.
• Present some chronic disease in clinical manifestation.
• Being pregnant or intending to become pregnant.
• Be in breastfeeding period.
• Being unable to follow the study guidelines.

Sponsors & Collaborators

• Technological Centre of Nutrition and Health, Spain: lead
• Fundació Eurecat: collaborator
• Hospital Universitari Sant Joan de Reus: collaborator
• University Rovira i Virgili: collaborator
• Pharmactive Biotech Products S.L.: collaborator

Study Sites (1)

Centro Tecnológico de Nutrición y Salud (Eurecat-Reus)

Reus, Tarragona, 43203, Spain

Location

Related Links

• Technological Centre of Nutrition and Health. Eurecat\_Reus.

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Rosa Solà, Dr

  Centro Tecnológico de Nutrición y Salud (Eurecat_Reus). Reus, Tarragona, Spain.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The consumption of SANE and placebo will be in the form of tablets with the same appearance, of 550 mg / tablet, guaranteeing that the study is blind both for the researchers of the project and for the participants (double blind).
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2019
• First Posted: July 8, 2019
• Study Start: July 24, 2019
• Primary Completion: December 19, 2019
• Study Completion: December 19, 2019
• Last Updated: February 28, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)