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.
Condition or disease | Intervention/treatment | Phase |
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Cardiovascular Diseases | Dietary Supplement: Aged black garlic extract Dietary Supplement: Placebo | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Masking Description: | 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). |
Primary Purpose: | Prevention |
Official Title: | Effect of a Black Garlic Extract With Greater Concentration of Bioactive Compounds and Lower Content in Undesired Compounds on Cholesterol LDL Levels. Chronic, Randomized, Crossover, Controled and Double Blind Study |
Estimated Study Start Date : | July 2019 |
Estimated Primary Completion Date : | January 2020 |
Estimated Study Completion Date : | March 2020 |
Arm | Intervention/treatment |
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Experimental: Extract of aged black garlic
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) .
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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. |
Placebo Comparator: Placebo
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).
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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.
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Rosa M Valls, PhD | 0034 636944723 | estudis@ctns.cat | |
Contact: Anna Crescenti, PhD | +34977770958 | anna.crescenti@eurecat.org |
Spain | |
Centro Tecnológico de Nutrición y Salud (Eurecat-Reus) | |
Reus, Tarragona, Spain, 43203 | |
Contact: Rosa M Valls, PhD +34 636 944 723 estudis@ctns.cat | |
Contact: Anna Crescenti, PhD +34 977 77 09 58 anna.crescenti@eurecat.org |
Principal Investigator: | Rosa Solà, Dr | Centro Tecnológico de Nutrición y Salud (Eurecat_Reus). Reus, Tarragona, Spain. |
Tracking Information | |||||
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First Submitted Date ICMJE | July 3, 2019 | ||||
First Posted Date ICMJE | July 8, 2019 | ||||
Last Update Posted Date | July 8, 2019 | ||||
Estimated Study Start Date ICMJE | July 2019 | ||||
Estimated Primary Completion Date | January 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
LDL-c levels [ Time Frame: At week 1, week 3 and week 6 for each of the two treatments (SANE and placebo). ] Serum LDL-c levels will be measured by standardized methods in Cobas Mira Plus autoanalyzer (Roche Diagnostics Systems, Madrid, Spain).
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Effect of a Black Garlic Extract on Cholesterol LDL Levels | ||||
Official Title ICMJE | Effect of a Black Garlic Extract With Greater Concentration of Bioactive Compounds and Lower Content in Undesired Compounds on Cholesterol LDL Levels. Chronic, Randomized, Crossover, Controled and Double Blind Study | ||||
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. |
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Detailed Description |
Chronic, randomized, crossover, placebo-controlled and double-blind nutritional intervention trial. The 60 participants in the study will be randomly divided into two groups of 30 participants, as they begin the study taking the SANE or placebo for 6 weeks. At the end of study week 6, when the first treatment is finished, a 3-week washout period will be carried out, and then the treatment that will take place during another 6 weeks will be exchanged. Total study duration of 15 weeks. The dose of SANE will be 250 mg daily, presented in a tablet of 550 mg / unit. The placebo will be microcrystalline cellulose. 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). The tablets will be presented in recipients of 45 units, so that with one recipient the participants will be able to carry out the entire intervention for each of the products. Adverse effects will be controlled: body odor, halitosis, flatulence, nausea, abdominal distension, reflux and allergic reactions. During the study, volunteers will perform 7 visits, according to the cross-type study design.
In all the visits the participants must present themselves in fasting conditions of 8 hours to obtain blood. In addition, at each visit (except in the case of V0) a questionnaire will be conducted to determine the presence / absence of adverse effects. Main variable: LDL-c concentrations. Secondary variables:
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Masking Description: 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). Primary Purpose: Prevention
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Condition ICMJE | Cardiovascular Diseases | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Unknown status | ||||
Estimated Enrollment ICMJE |
60 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | March 2020 | ||||
Estimated Primary Completion Date | January 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Spain | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04010565 | ||||
Other Study ID Numbers ICMJE | ESACTIVO | ||||
Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Technological Centre of Nutrition and Health, Spain | ||||
Study Sponsor ICMJE | Technological Centre of Nutrition and Health, Spain | ||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Technological Centre of Nutrition and Health, Spain | ||||
Verification Date | June 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |