Clinical Trial to Evaluate the Reduction of Cardiovascular Risk (NUT)

Universidad Católica San Antonio de Murcia

Status

Completed

Conditions

Cholesterol

Treatments

Dietary Supplement: maltodextrina

Dietary Supplement: Apigenin, luteonin, grapefruit extract and citrolive

Study type

Interventional

Funder types

Other

Identifiers

NCT04114916

UCAMCFE-0005

Details and patient eligibility

About

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.

Enrollment

100 patients

Sex

Female

Ages

45 to 75 years old

Volunteers

Accepts Healthy Volunteers

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 / m2.
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).
Subjects under treatment with niacin or fibrates.
Those subjects with alcohol abuse, or with excessive alcohol consumption (> 3 glasses of wine or beer / day) will be excluded.
Patients undergoing major surgery in the last 3 months.
Subjects who smoke or not, but in any case who do not modify their nicotinic habits during their participation in the study.
Participation in another clinical trial in the three months prior to the study Lack of will or inability to comply with clinical trial procedures.