Status:
COMPLETED
Effect of a Dietary Supplement on Lipid Pattern and Liver Parameters in Hypercholesterolemia
Lead Sponsor:
University of Bologna
Conditions:
Hypercholesterolemia
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
The joint ESC/EAS guidelines for the management of dyslipidaemias recommend, for patients at low/moderate CV risk with raised LDL-C, a set of measures collectively defined as "lifestyle interventions"...
Eligibility Criteria
Inclusion
- Subjects agree to participate in the study and having dated and signed the informed consent form.
- Subjects who have the capability to communicate, to make themselves understood, and to comply with the study's requirements.
- Male or female aged ≥ 18 years and ≤ 70 years old.
- LDL-Cholesterol plasma levels \>115 mg/dL and \< 190 mg/dL.
- TG\<400 mg/dL.
- Subjects who, according to the SCORE charts, have a low or moderate cardiovascular risk (defined as a total cardiovascular risk \< 5%) and for whom, according to ESC/EAS guidelines 2012, the intervention strategy does not require a pharmacological lipid-lowering intervention.
Exclusion
- Subjects already affected by cardiovascular diseases (secondary prevention) or with estimated 10 years cardiovascular disease risk\> 5%;
- Obesity (BMI\>30 kg/m2) or diabetes mellitus;
- Assumption of lipid lowering drugs or food supplements, or drugs potentially affecting the lipid metabolism;
- Antihypertensive treatment not stabilized since at least 3 months;
- Anticoagulants therapy
- Uncontrolled hypertension (systolic blood pressure\> 190 mmHg or diastolic arterial pressure\> 100 mmHg);
- Known current thyroid, gastrointestinal or hepatobiliary diseases;
- Any medical or surgical condition that would limit the patient adhesion to the study protocol;
- Abuse of alcohol or drugs (current or previous);
- History of malignant neoplasia in the 5 years prior to enrolment in the study;
- History or clinical evidence of inflammatory disease such as severe arthritis, systemic lupus erythematosus or chronic inflammatory diseases or current therapy with immunosuppressive agents or long-term glucocorticoids;
- History or clinical evidence of any significant concomitant disease that could compromise the safety of the subject or the possibility of completing the study;
- Known previous intolerance to the tested nutraceutical
- Women in fertile age not using consolidated contraceptive methods
- Pregnancy and Breastfeeding.
Key Trial Info
Start Date :
September 21 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 4 2021
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04485793
Start Date
September 21 2020
End Date
October 4 2021
Last Update
January 31 2024
Active Locations (1)
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1
University of Bologna
Bologna, BO, Italy, 40138