Clinical Trial to Evaluate the Efficacy of a Nutraceutical Versus Placebo in Reducing Cardiovascular Risk in Healthy Subjects

Universidad Católica San Antonio de Murcia1 site in 1 country72 target enrollmentNovember 11, 2019

ConditionsCardiovascular Risk

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Cardiovascular Risk
Sponsor: Universidad Católica San Antonio de Murcia
Enrollment: 72
Locations: 1
Primary Endpoint: Total Cholesterol
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Detailed 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.

Registry

clinicaltrials.gov

Start Date

November 11, 2019

End Date

September 18, 2020

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Universidad Católica San Antonio de Murcia

Responsible Party

Principal Investigator

Francisco Javier López Román

Principal Investigator

Universidad Católica San Antonio de Murcia

Eligibility Criteria

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 / m
•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.

Outcomes

Primary Outcomes

Total Cholesterol

Time Frame: It is measured on an empty stomach, change after 56 days of consumption.

Lipidic profile, measured in mg/dl

HDL - Cholesterol

Time Frame: It is measured on an empty stomach, change after 56 days of consumption.

Lipidic profile, measured in mg/dl

LDL - Cholesterol

Time Frame: It is measured on an empty stomach, change after 56 days of consumption.

Lipidic profile, measured in mg/dl

Triglycerides

Time Frame: It is measured on an empty stomach, change after 56 days of consumption.

Lipidic profile, measured in mg/dl

Secondary Outcomes

Oxidized LDL(It is measured on an empty stomach, before and after the consumption time (56 days).)
Superoxide Dismutase (SOD)(It is measured on an empty stomach, before and after the consumption time (56 days).)
Physical Activity Questionnaire(It is measured before and after the consumption time (56 days).)
Glycosylated hemoglobin (HBA1c)(It is measured on an empty stomach, before and after the consumption time (56 days).)
Fat mass(It is measured on an empty stomach, before and after the consumption time (56 days).)
Muscle mass(It is measured on an empty stomach, before and after the consumption time (56 days).)
Body mass index(It is measured on an empty stomach, before and after the consumption time (56 days).)
Percentage of fat mass(It is measured on an empty stomach, before and after the consumption time (56 days).)
Interleukin-6 (IL-6)(It is measured on an empty stomach, before and after the consumption time (56 days).)
Assessing a change of blood pressure(Blood pressure measurements will be taken with a Holter monitor on two separate occasions and for 24 hours each day. Measurements were made at baseline and after 56 days of product consumption. Systolic and diastolic blood pressure will be measured)
Blood glucose(It is measured on an empty stomach, before and after the consumption time (56 days).)
malondialdehyde (MDA)(It is measured on an empty stomach, before and after the consumption time (56 days).)
Proteins C Reactive (PCR)(It is measured on an empty stomach, before and after the consumption time (56 days).)
Control of dietary intake(A nutritional registry will be carried out. The nutritional intake of three days in two periods will be collected. One record at the beginning and another at the end, that is, six days.)
Liver safety variables(It is measured on an empty stomach, before and after the consumption time (56 days).)