CITROXI: Clinical Trial on the Effectiveness of Citrolive

• Sponsor: Universidad Católica San Antonio de Murcia (Other)
• Overall Status: Completed
• CT.gov ID: NCT04330937
• Collaborator: (none)
• Enrollment: 23
• Location: 1
• Arms: 2
• Actual Duration (Months): 28
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Risk	Dietary Supplement: dietetics	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 23 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Clinical Trial on the Effectiveness of Citrolive® to Decrease Oxidation of Low Density Lipoproteins
• Actual Study Start Date: Oct 1, 2017
• Actual Primary Completion Date: Nov 30, 2019
• Actual Study Completion Date: Feb 1, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Blood pressure [The change in systolic and diastolic blood pressure is observed after three months of intake of the product under investigation]

   The systolic and diastolic blood pressure was measured with an OMRON oscilimétrilo sphygmomanometer

2. Biochemistry and blood count [The change is observed after three months of intake of the product under investigation]

   the hematological profile is analyzed with the Horiba ABX Oentra 80 analyzer. Biochemical profile with the ILAB 600 analyzer

Secondary Outcome Measures

1. Weight [The change is observed after three months of intake of the product under investigation]

   Measured in Kg.

2. Height [The change is observed after three months of intake of the product under investigation]

   Measured in cm.

3. BMI [The change is observed after three months of intake of the product under investigation]

   Weight and height are combined for BMI report in kg / m ^ 2

4. Perimeters [The change is observed after three months of intake of the product under investigation]

   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).

5. Folds [The change is observed after three months of intake of the product under investigation]

   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).

6. Diameters [The change is observed after three months of intake of the product under investigation]

   Measured in cm. Radiocubital or wrist biestiloid, humeral or elbow bicpicondiolo, femoral or knee bicondiol.

7. Nutritional record [Measurements are made at the beginning and after 90 days of product consumption.]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Catholic University of Murcia	Murcia		Spain	30107

Sponsors and Collaborators

• Universidad Católica San Antonio de Murcia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Francisco Javier López Román, Principal Investigator, Universidad Católica San Antonio de Murcia
• ClinicalTrials.gov Identifier: NCT04330937
• Other Study ID Numbers: UCAMCFE-0008
• First Posted: Apr 2, 2020
• Last Update Posted: Apr 2, 2020
• Last Verified: Mar 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Apr 2, 2020