Cardiovascular Health
Conditions
Keywords
Garlic, Onion, LDL cholesterol, Cardiovascular health
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTGarlic and onion concentrate
Garlic extract concentrate (equivalent to 2 garlic cloves) and onion extract concentrate (equivalent to 1 onion).
DIETARY_SUPPLEMENTControl
Microcrystalline cellulose
Sponsors
DOMCA S.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Each volunteer is assigned a participant number that will be associated with a pot that will have all the product for the study. The pot number is the same as the participant number.
Intervention model description
Controlled, randomized, double-blind, parallel group nutritional intervention study.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* LDL-cholesterol levels between 100 and 190 mg/dL. * Freely agree to participate in the study and sign the informed consent document.
Exclusion criteria
* Be pregnant. * Have planned to change lifestyle and / or dietary habits. * Having diabetes. * Having a cerebrovascular disease. * Having a serious illness. * Taking products or drugs to control cholesterol levels or with antioxidant activity.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| LDL | 8 weeks. | Serum LDL cholesterol |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HDL | 8 weeks | Serum HDL cholesterol |
| Triglycerides | 8 weeks | Serum triglycerides |
| Glucose | 8 weeks | Serum glucose |
| CRP | 8 weeks | C-reactive protein in serum |
| Oxidized LDL cholesterol | 8 weeks | Oxidized LDL cholesterol in plasma |
| MDA | 8 weeks | Malondialdehyde in plasma |
| TAC | 8 weeks | Plasma total antioxidant capacity |
| Selenium | 8 weeks | Serun selenium |
| Cholesterol | 8 weeks | Serum total cholesterol |
| VCAM-1 | 8 weeks | Endothelial adhesion molecules VCAM-1 in plasma |
| ICAM-1 | 8 weeks | Endothelial adhesion molecules ICAM-1 in plasma |
| IL1 beta in plasma | 8 weeks | Interleukin-1 beta in plasma |
| IL 6 | 8 weeks | Interleukin-6 in plasma |
| IL 10 | 8 weeks | Interleukin-10 in plasma |
| BMI | 8 weeks | Body mass index (height/weight ratio) |
| Abdominal perimeter | 8 weeks | Abdominal perimeter in centimeters |
| Blood pressure | 8 weeks | Systolic pressure and diastolic pressure) |
| Selenoprotein P | 8 weeks | Selenoprotein P in plasma |
Countries
Spain
Outcome results
None listed