Status:
COMPLETED
To Evaluate the Efficacy of a Nutraceutical in Reducing Cardiovascular Risk in Healthy Subjects
Lead Sponsor:
Universidad Católica San Antonio de Murcia
Conditions:
Cardiovascular Risk
Eligibility:
All Genders
18-65 years
Phase:
NA
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 objec...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 11 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 18 2020
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT04506749
Start Date
November 11 2019
End Date
September 18 2020
Last Update
September 29 2020
Active Locations (1)
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1
Catholic University of Murcia
Murcia, Spain, 30107