Clinical Trial on the Effectiveness of Citrolive

Cardiovascular Risk Clinical Trial

— CITROXI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04330937
• Other study ID #: UCAMCFE-0008
• Status: Completed
• Phase: N/A
• Start date: October 1, 2017
• Est. completion date: February 1, 2020

Study information

• Verified date: March 2020
• Source: Universidad Católica San Antonio de Murcia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: February 1, 2020
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. 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.

2. 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.

3. 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.

Related Conditions & MeSH terms

• Cardiovascular Risk

Intervention

Dietary Supplement:
• dietetics
90 days of consumption

Locations

Country	Name	City	State
Spain	Catholic University of Murcia	Murcia

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Católica San Antonio de Murcia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Weight	Measured in Kg.	The change is observed after three months of intake of the product under investigation
Secondary	Height	Measured in cm.	The change is observed after three months of intake of the product under investigation
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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.