Clinical Trial on the Effectiveness of Citrolive

Study Overview
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Brief Summary
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The clinical trial consists in checking the antioxidant effect of citrolive on low density cholesterol.

Detailed Description
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The clinical trial consists in checking the antioxidant effect of citrolive on low density cholesterol. To do this, volunteers consume the product under study or placebo for three months. Tests will be performed before and after ingestion of the product.

Official Title
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Clinical Trial on the Effectiveness of Citrolive® to Decrease Oxidation of Low Density Lipoproteins

Conditions
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Cardiovascular Risk

Intervention / Treatment
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* Dietary Supplement: dietetics


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Not belonging to the group of individuals considered as priorities by the Third Joint Task Force for the prevention of cardiovascular diseases due to high risk. Present total cholesterol figures greater than 200 milligrams / deciliter and / or low density cholesterol figures greater than 130 milligrams / deciliter so that after applying the cardiovascular risk table (SCORE) they present a current risk of less than 5% of suffer an ischemic event in a period of 10 years, being without pharmacological treatment. Present several cardiovascular risk factors with cholesterolemia figures close to 200 milligrams / deciliters and / or low density cholesterol figures close to 130 milligrams / deciliters. Exclusion Criteria: 1. chronic or terminal illness.

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
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental group<br>volunteers consume 1 capsule per day for 3 months. (500 mg citrolive). | Dietary Supplement: dietetics<br>* 90 days of consumption<br>|
| Placebo Comparator: control group Placebo (sucrose)<br>volunteers consume 1 capsule per day for 3 months. (saccharose). | Dietary Supplement: dietetics<br>* 90 days of consumption<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure | The systolic and diastolic blood pressure was measured with an OMRON oscilimétrilo sphygmomanometer | The change in systolic and diastolic blood pressure is observed after three months of intake of the product under investigation | 
| Biochemistry and blood count | the hematological profile is analyzed with the Horiba ABX Oentra 80 analyzer. Biochemical profile with the ILAB 600 analyzer | The change is observed after three months of intake of the product under investigation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight | Measured in Kg. | The change is observed after three months of intake of the product under investigation | 
| Height | Measured in cm. | The change is observed after three months of intake of the product under investigation | 
| BMI | Weight and height are combined for BMI report in kg / m ^ 2 | The change is observed after three months of intake of the product under investigation | 
| Perimeters | Measured in cm. Waist, hip, waist / hip index, relaxed biceps, contracted biceps, medial thigh, twin or calf. Folds (mm) (tricipítal, subscapular, suprailiac anterior or supraspinal, abdominal, quadricipital or thigh, leg or calf medial, bicipital, iliocrestal). Diameters (cm) (radiocubital or wrist biestiloid, humeral or elbow bicpicondiolo, femoral or knee bicondiol). | The change is observed after three months of intake of the product under investigation | 
| Folds | Measured in mm. Tricipítal, subscapular, suprailiac anterior or supraspinal, abdominal, quadricipital or thigh, leg or calf medial, bicipital, iliocrestal. Diameters (cm) (radiocubital or wrist biestiloid, humeral or elbow bicpicondiolo, femoral or knee bicondiol). | The change is observed after three months of intake of the product under investigation | 
| Diameters | Measured in cm. Radiocubital or wrist biestiloid, humeral or elbow bicpicondiolo, femoral or knee bicondiol. | The change is observed after three months of intake of the product under investigation | 
| Nutritional record | Volunteers record dietary intake for three days in a notebook. They will describe the amount of food they consume in grams in order to assess changes in intake during the clinical trial. | Measurements are made at the beginning and after 90 days of product consumption. |