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Trial record 42 of 83 for:    Taste Disorders AND sense

Effect of a Black Garlic Extract on Cholesterol LDL Levels (ESACTIVO)

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ClinicalTrials.gov Identifier: NCT04010565
Recruitment Status : Not yet recruiting
First Posted : July 8, 2019
Last Update Posted : July 8, 2019
Sponsor:
Collaborators:
Eurecat
Hospital Universitari Sant Joan de Reus
University Rovira i Virgili
Pharmactive Biotech Products S.L.
Information provided by (Responsible Party):
Technological Centre of Nutrition and Health, Spain

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.


Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Dietary Supplement: Aged black garlic extract Dietary Supplement: Placebo Not Applicable

  Show Detailed Description

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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
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) .
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).
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.




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. Measures of body weight [ Time Frame: At week 1, week 3 and week 6 for each of the two treatments (SANE and placebo). ]
    Body weight measured by TANITA SC330.

  2. Measures of height [ Time Frame: At week 1, week 3 and week 6 for each of the two treatments (SANE and placebo). ]
    Height measured by standardized methods.

  3. Measures of BMI [ Time Frame: At week 1 for each of the two treatments (SANE and placebo). ]
    Weight and height will be combined to report BMI in kg/m^2.

  4. Measures of waist circumference [ Time Frame: At week 1, week 3 and week 6 for each of the two treatments (SANE and placebo). ]
    Waist circumference using a measuring tape.

  5. Bood pressure (measured in mmHg) [ Time Frame: At week 1, week 3 and week 6 for each of the two treatments (SANE and placebo). ]
    Systolic and diastolic blood pressure will be measured twice after 2-5 minutes of patient respite, seated, with one-minute interval in between, using an automatic sphygmomanometer (OMRON HEM-907; Peroxfarma, Barcelona, Spain).

  6. Lipid metabolism [ Time Frame: At week 1, week 3 and week 6 for each of the two treatments (SANE and placebo). ]
    Total cholesterol, HDL-c, TG, NEFAs, Apo B and Apo A1 plasma levels will be measured by standardized methods in Cobas Mira Plus autoanalyzer (Roche Diagnostics Systems, Madrid, Spain). oxLDL, PLTP plasma levels will be measured by human ELISA kits.

  7. Glucose metabolism [ Time Frame: At week 1, week 3 and week 6 for each of the two treatments (SANE and placebo). ]
    Glucose and insulin plasma levels will be measured by standardized methods in Cobas Mira Plus autoanalyzer (Roche Diagnostics Systems, Madrid, Spain).

  8. Inflammation [ Time Frame: At week 1, week 3 and week 6 for each of the two treatments (SANE and placebo). ]
    IL-6 plasma levels will be measured by standardized methods in Cobas Mira Plus autoanalyzer (Roche Diagnostics Systems, Madrid, Spain). MCP-1 and TNF alpha will be measured by human ELISA kits.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. BMI ≥ 35 kg/m^2
  2. LDL-c serum levels <115 mg/dL
  3. Serum glucose levels higher than 126 mg/dL
  4. 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.
  5. Be a smoker
  6. Follow a hypocaloric diet and/or pharmacological treatment for weight loss.
  7. Anti-hypertensive treatment.
  8. Presenting anemia (hemoglobin ≤ 13 g/dL in men and ≤ 12 g/dL in women).
  9. Present some chronic gastrointestinal disease.
  10. Present some chronic disease in clinical manifestation.
  11. Being pregnant or intending to become pregnant.
  12. Be in breastfeeding period.
  13. Participate in or have participated in a clinical trial or nutritional intervention study in the last 30 days prior to inclusion in the study.
  14. Being unable to follow the study guidelines.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04010565


Contacts
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Contact: Rosa M Valls, PhD 0034 636944723 estudis@ctns.cat
Contact: Anna Crescenti, PhD +34977770958 anna.crescenti@eurecat.org

Locations
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Spain
Centro Tecnológico de Nutrición y Salud (Eurecat-Reus) Not yet recruiting
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   
Sponsors and Collaborators
Technological Centre of Nutrition and Health, Spain
Eurecat
Hospital Universitari Sant Joan de Reus
University Rovira i Virgili
Pharmactive Biotech Products S.L.
Investigators
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Principal Investigator: Rosa Solà, Dr Centro Tecnológico de Nutrición y Salud (Eurecat_Reus). Reus, Tarragona, Spain.

Additional Information:
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Responsible Party: Technological Centre of Nutrition and Health, Spain
ClinicalTrials.gov Identifier: NCT04010565     History of Changes
Other Study ID Numbers: ESACTIVO
First Posted: July 8, 2019    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Technological Centre of Nutrition and Health, Spain:
Cholesterol LDL
Black garlic extract
S-allyl cysteine

Additional relevant MeSH terms:
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Cardiovascular Diseases
Titanium dioxide
Sunscreening Agents
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs
Dermatologic Agents
Photosensitizing Agents