Clinical trial NCT04574505: Food Supplementation With Eufortyn Colesterolo Plus for LDL Modulation in Subjects With Polygenic Hypercholesterolemia
Official title: Evaluation of the Effect of a Food Supplementation With Eufortyn Colesterolo Plus on the Modulation of LDL Cholesterolemia in Subjects Affected by Polygenic Hypercholesterolemia: a Two-arm Double-blind, Placebo- Controlled, Randomized, Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypercholesterolemia
Lead sponsor: University of Bologna
Sponsor class: OTHER
Collaborators: name: SCHARPER Spa
First posted: 2020-10-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a two-arm randomized, placebo-controlled, double-blind, monocentric parallel-groups clinical study conducted in Italy.
Primary purpose: TREATMENT

Brief summary: This is a two-arm randomized, placebo-controlled, double-blind, monocentric parallel-groups clinical study conducted in Italy.

The objective of this study is to evaluate the effect of dietary supplementation of a combined supplement containing bergamot (Vazguard®) phytosomal polyphenolic fraction associated with standardized artichoke extract (Pycrinil®, Cynara cardunculus) and Cynara scolimus, associated with high coenzyme Q10 bioavailability (Q10 phytosome® Ubiqsome) and zinc, on the glycometabolic structure of subjects with suboptimal levels of LDL cholesterolemia compared with placebo.


Eligibility criteria: Inclusion Criteria:

* 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 2019, the intervention strategy does not require a pharmacological lipid lowering intervention.

Exclusion Criteria:

* 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 one component of the tested nutraceuticals
* Women in fertile age not using consolidated contraceptive methods
* Pregnancy and Breastfeeding.

Primary outcomes:
measure: The primary objective is to compare the effect on LDL-cholesterol after 8 weeks of treatment with a combined food supplement with placebo (standard diet only).
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: AOU Policlinico S.Orsola-Malpighi
Study officials:
affiliation: University of Bologna
name: Arrigo Cicero, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fogacci F, Rizzoli E, Giovannini M, Bove M, D'Addato S, Borghi C, Cicero AFG. Effect of Dietary Supplementation with Eufortyn(R) Colesterolo Plus on Serum Lipids, Endothelial Reactivity, Indexes of Non-Alcoholic Fatty Liver Disease and Systemic Inflammation in Healthy Subjects with Polygenic Hypercholesterolemia: The ANEMONE Study. Nutrients. 2022 May 18;14(10):2099. doi: 10.3390/nu14102099.