Status:
COMPLETED
Clinical Trial to Evaluate the Reduction of Cardiovascular Risk
Lead Sponsor:
Universidad Católica San Antonio de Murcia
Conditions:
Cholesterol
Eligibility:
FEMALE
45-75 years
Phase:
NA
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 ei...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2018
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04114916
Start Date
October 1 2016
End Date
December 30 2018
Last Update
October 3 2019
Active Locations (1)
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1
Catholic University of Murcia
Murcia, Spain, 30107