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Completed

NCT Number: NCT04330937

Clinical Trial on the Effectiveness of Citrolive

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

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Key information

Conditions

Cardiovascular Risk

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Catholic University of Murcia

Murcia, 30107, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • chronic or terminal illness.

Treatment and study plan

dietetics

Dietary Supplement

90 days of consumption

Primary outcomes

  1. Blood pressure

    Time frame: 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

    Time frame: 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 outcomes

  1. Weight

    Time frame: The change is observed after three months of intake of the product under investigation

    Measured in Kg.

  2. Height

    Time frame: The change is observed after three months of intake of the product under investigation

    Measured in cm.

  3. BMI

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Universidad Católica San Antonio de Murcia

Other

Registry information

Official study title

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

Acronym: CITROXI

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Apr 2, 2020
Registry last updated
Apr 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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