Effect of a Mixture of Allium Extracts on LDL Cholesterol Levels Volunteers With Elevated LDL Cholesterol Levels

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of the Effect of Consuming a Mixture of Concentrated Allium Extracts on LDL Cholesterol Levels in Healthy Volunteers With Elevated LDL Cholesterol Levels

Conditions
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Cardiovascular Health

Intervention / Treatment
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* Dietary Supplement: Garlic and onion concentrate
* Dietary Supplement: Control


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Controlled, randomized, double-blind, parallel group nutritional intervention study.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>Microcrystalline cellulose (9892- Capsules®) up to 400 mg. | Dietary Supplement: Garlic and onion concentrate<br>* Garlic extract concentrate (equivalent to 2 garlic cloves) and onion extract concentrate (equivalent to 1 onion).<br>* Other names: AlioCare;Dietary Supplement: Control<br>* Microcrystalline cellulose<br>* Other names: Excipient;|
| Experimental: Intervention<br>Garlic concentrated extract. Onion concentrated extract. Microcrystalline cellulose (9892- Capsules®) up to 400 mg. | Dietary Supplement: Garlic and onion concentrate<br>* Garlic extract concentrate (equivalent to 2 garlic cloves) and onion extract concentrate (equivalent to 1 onion).<br>* Other names: AlioCare;Dietary Supplement: Control<br>* Microcrystalline cellulose<br>* Other names: Excipient;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LDL | Serum LDL cholesterol | 8 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cholesterol | Serum total cholesterol | 8 weeks | 
| HDL | Serum HDL cholesterol | 8 weeks | 
| Triglycerides | Serum triglycerides | 8 weeks | 
| Glucose | Serum glucose | 8 weeks | 
|  | Nitric oxide in serum | 8 weeks | 
| CRP | C-reactive protein in serum | 8 weeks | 
| Oxidized LDL cholesterol | Oxidized LDL cholesterol in plasma | 8 weeks | 
| MDA | Malondialdehyde in plasma | 8 weeks | 
| TAC | Plasma total antioxidant capacity | 8 weeks | 
| Selenium | Serun selenium | 8 weeks | 
| Selenoprotein P | Selenoprotein P in plasma | 8 weeks | 
| VCAM-1 | Endothelial adhesion molecules VCAM-1 in plasma | 8 weeks | 
| ICAM-1 | Endothelial adhesion molecules ICAM-1 in plasma | 8 weeks | 
| IL1 beta in plasma | Interleukin-1 beta in plasma | 8 weeks | 
| IL 6 | Interleukin-6 in plasma | 8 weeks | 
| IL 10 | Interleukin-10 in plasma | 8 weeks | 
| BMI | Body mass index (height/weight ratio) | 8 weeks | 
| Abdominal perimeter | Abdominal perimeter in centimeters | 8 weeks | 
| Blood pressure | Systolic pressure and diastolic pressure) | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Garlic, Onion, LDL cholesterol, Cardiovascular health