Status:
COMPLETED
Effect of a Black Garlic Extract on Cholesterol LDL Levels
Lead Sponsor:
Technological Centre of Nutrition and Health, Spain
Collaborating Sponsors:
Fundació Eurecat
Hospital Universitari Sant Joan de Reus
Conditions:
Cardiovascular Diseases
Eligibility:
All Genders
18+ years
Phase:
NA
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). Recent...
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 th...
Eligibility Criteria
Inclusion
- Men and women over 18 years of age.
- Fasting serum LDL-c concentration ≥ 115 mg/dL.
- Sign the informed consent.
Exclusion
- 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.
- Participate in or have participated in a clinical trial or nutritional intervention study in the last 30 days prior to inclusion in the study.
- Being unable to follow the study guidelines.
Key Trial Info
Start Date :
July 24 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 19 2019
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT04010565
Start Date
July 24 2019
End Date
December 19 2019
Last Update
February 28 2022
Active Locations (1)
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1
Centro Tecnológico de Nutrición y Salud (Eurecat-Reus)
Reus, Tarragona, Spain, 43203