Clinical Trial on the Effectiveness of Citrolive (CITROXI)

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

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

Study Overview

• Status: Completed
• Conditions: Cardiovascular Risk
• Intervention / Treatment: Dietary supplement: dietetics

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Murcia, Spain, 30107
    • Catholic University of Murcia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Universidad Católica San Antonio de Murcia

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2017
• Primary Completion (Actual): November 30, 2019
• Study Completion (Actual): February 1, 2020

Study Registration Dates

• First Submitted: October 16, 2019
• First Submitted That Met QC Criteria: March 30, 2020
• First Posted (Actual): April 2, 2020

Study Record Updates

• Last Update Posted (Actual): April 2, 2020
• Last Update Submitted That Met QC Criteria: March 30, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: UCAMCFE-0008

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No