To Evaluate the Efficacy of a Nutraceutical in Reducing Cardiovascular Risk in Healthy Subjects (JC)

Universidad Católica San Antonio de Murcia

Status

Completed

Conditions

Cardiovascular Risk

Treatments

Dietary Supplement: Dietary supplement consumption

Study type

Interventional

Funder types

Other

Identifiers

NCT04506749

UCAMCFE-00015

Details and patient eligibility

About

Single-blind, double-blind, controlled, randomized clinical trial of two parallel branches depending on the product consumed (experimental product and placebo product) and single-center with the objective of evaluating the effect of the investigational product on cardiovascular risk reduction.

Full description

Subjects who meet the selection criteria will make a total of two visits to the research laboratory and will carry out the tests established in the protocol. Subsequently, a statistical analysis will be performed with the variables measured in the study to obtain results.

Enrollment

72 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Subjects of both sexes (men or women) between 30 and 75 years of age, Caucasian.
Present body mass index between 20 and 32 Kg / m2.
Presenting fasting serum LDL-cholesterol levels equal to or greater than 110 mg / dL or total serum cholesterol equal to or greater than 180 mg / dL.
Volunteers capable of understanding the clinical study and willing to grant written informed consent and to comply with study procedures and requirements.

Exclusion criteria

Thyroid dysfunction, infections, or with any type of chronic disease (eg, autoimmune, inflammatory).
Subjects who have suffered an ischemic-vascular event in the last months.
Subjects in medication and / or nutraceutical treatment for hypertension, diabetes or hyperlipidemia (ex: statins).
Subjects in treatment with drugs that due to their narrow therapeutic margin require monitoring of their plasma levels (digoxin, acenocoumarol, warfarin, etc ...).
Subjects in treatment that affects body weight or appetite.
History of allergic hypersensitivity or poor tolerance to any component of the products under study.
Subjects who are carrying out or intend to carry out any type of diet, low-calorie or not, during the study.
Subjects who have donated a minimum of 0.5L of blood in the last month Vegetarian subjects.
Subjects who have ingested omega 3 and / or 6 supplements in the last three months, (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) were excluded.
Patients undergoing major surgery in the last 3 months.
Smoking subjects or not, but in any case who have changed 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.
Subjects whose condition did not make them eligible for the study according to the researcher's criteria.