Clinical Trial to Evaluate the Efficacy of a Nutraceutical Versus Placebo in Reducing Cardiovascular Risk in Healthy Subjects.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cholesterol
- Sponsor
- Universidad Católica San Antonio de Murcia
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- endothelial function
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
Randomized parallel and double blind clinical trial in which it is intended to analyze the efficacy of a nutraceutical on cholesterol and endothelial function after the consumption of a product for eight weeks.
Investigators
Francisco Javier López Román
Principal Investigator
Universidad Católica San Antonio de Murcia
Eligibility Criteria
Inclusion Criteria
- •Subjects of both sexes (men or women) between 40 and 75 years of age, of Caucasian race
- •Women must be in the menopausal period.
- •Present body mass index between 18.5 and 34.9 Kg / m
- •The number of platelets in whole blood must be greater than 170 x109 / L
- •Hematocrit greater than 40% for men or greater than 35% for women.
- •Hemoglobin greater than 120 g / L for men or 110 g / L for women.
- •Present fasting levels of LDL-serum cholesterol equal to or greater than 110mg / dL
- •Present fasting values of total serum cholesterol equal or superior to 180mg / dL
- •Volunteers able to understand the clinical study and willing to give written informed consent and to comply with the procedures and requirements of the study.
Exclusion Criteria
- •Thyroid dysfunction, infections, or with any type of chronic disease (for example, autoimmune, inflammatory).
- •Subjects who have suffered an ischemic-vascular event during the last months
- •Subjects undergoing medication and / or nutraceutical treatment for hypertension, diabetes or hyperlipidemia (eg Statins).
- •Subjects under treatment with drugs that due to their narrow therapeutic margin require monitoring of their plasma levels (digoxin, acenocoumarol, warfarin, etc ...)
- •Subjects under treatment that affect body weight or appetite.
- •History of allergic hypersensitivity or poor tolerance to any component of the products under study.
- •Subjects who are performing or intend to perform any type of diet, hypocaloric or not, during the conduct of the study.
- •Subjects who have donated a minimum of 0.5L of blood in the last month.
- •Vegetarian subjects.
- •Subjects, who have ingested, in the last three months, supplements of omega 3 and / or 6, (eg fish oil, evening primrose oil, krill oil, or algae oil).
Outcomes
Primary Outcomes
endothelial function
Time Frame: The measurements of endothelial function are taken with an ultrasound on two different occasions. The measurements will be made at baseline and after eight weeks of product consumption.
Changes in the dilatation of the Humeral artery.
blood samples
Time Frame: Total cholesterol measurements are taken with the ILAB 600 analyzer on two different occasions. The measurements are made at the beginning and after eight weeks of consumption of the product.
Change in total cholesterol levels.
Tests
Time Frame: Quality of life measurements are taken on two different occasions. Measurements are made at the beginning and after eight weeks of product consumption.
Change in the quality of life (SF-12).
nutritional record
Time Frame: The dietary intake will be controlled by a diary in which meals will be recorded for three days and on two different occasions. The measurements are made at the beginning and after eight weeks of consumption of the product.
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.
body composition
Time Frame: Body measurements are taken with a Tanita on two different occasions. The measurements are made at the beginning and after eight weeks of consumption of the product.
Changes in body composition were measured with a TANITA
cardiovascular risk
Time Frame: Cardiovascular risk measurements are taken by laboratory analysis on two different occasions. The measurements are made at the beginning and after eight weeks of consumption of the product.
Changes in systolic blood pressure (mmHg), dystolic blood pressure (mmHg) and heart rate (beats per minute).