To evaluate the efficacy of daily consumption of a combination of concentrated extracts of garlic (Allium sativum L.) and onion (Allium cepa L.) on LDL cholesterol levels in healthy volunteers. Parameters related to metabolic syndrome, cardiovascular health and the immune system will also be analyzed.
It is a controlled, randomized, double-blind, parallel-group nutritional intervention study. 64 healthy volunteers lwith elevated LDL cholesterol levels but who do not require pharmacological treatment will be randomly distributed into 2 equal groups: control group and intervention group. For 8 weeks the volunteers will take the product immediately after lunch. During that time they will maintain their lifestyle and nutritional habits. Blood samples will be taken at 0, 2, 4 and 8 weeks. Anthropometric parameters and health-related data were also measured. Parameters related to lipid metabolism, metabolic syndrome and the immune system will be analized.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
64
Garlic extract concentrate (equivalent to 2 garlic cloves) and onion extract concentrate (equivalent to 1 onion).
Microcrystalline cellulose
Domca Sau
Alhendín, Granada, Spain
LDL
Serum LDL cholesterol
Time frame: 8 weeks.
Cholesterol
Serum total cholesterol
Time frame: 8 weeks
HDL
Serum HDL cholesterol
Time frame: 8 weeks
Triglycerides
Serum triglycerides
Time frame: 8 weeks
Glucose
Serum glucose
Time frame: 8 weeks
Nitric oxide in serum
Time frame: 8 weeks
CRP
C-reactive protein in serum
Time frame: 8 weeks
Oxidized LDL cholesterol
Oxidized LDL cholesterol in plasma
Time frame: 8 weeks
MDA
Malondialdehyde in plasma
Time frame: 8 weeks
TAC
Plasma total antioxidant capacity
Time frame: 8 weeks
Selenium
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Serun selenium
Time frame: 8 weeks
Selenoprotein P
Selenoprotein P in plasma
Time frame: 8 weeks
VCAM-1
Endothelial adhesion molecules VCAM-1 in plasma
Time frame: 8 weeks
ICAM-1
Endothelial adhesion molecules ICAM-1 in plasma
Time frame: 8 weeks
IL1 beta in plasma
Interleukin-1 beta in plasma
Time frame: 8 weeks
IL 6
Interleukin-6 in plasma
Time frame: 8 weeks
IL 10
Interleukin-10 in plasma
Time frame: 8 weeks
BMI
Body mass index (height/weight ratio)
Time frame: 8 weeks
Abdominal perimeter
Abdominal perimeter in centimeters
Time frame: 8 weeks
Blood pressure
Systolic pressure and diastolic pressure)
Time frame: 8 weeks