Food Supplementation With Eufortyn Colesterolo Plus for LDL Modulation in Subjects With Polygenic Hypercholesterolemia

Hypercholesterolemia Clinical Trial

— ANEMONE  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04574505
• Other study ID #: SCH 01/2020
• Status: Completed
• Phase: N/A
• Start date: September 14, 2020
• Est. completion date: January 19, 2022

Study information

• Verified date: January 2024
• Source: University of Bologna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 19, 2022
• Est. primary completion date: November 19, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Dietary Supplement:
• Eufortyn Colesterolo Plus
Food supplement combination containing bergamot (Vazguard®) phytosomal polyphenolic fraction associated with standardized artichoke extract (Pycrinil®, Cynara Cardunculus L) and Cynara scolimus, associated with high coenzyme Q10 bioavailability(Q10 phytosome® Ubiqsome) and zinc.
• Placebo
Placebo

Locations

Country	Name	City	State
Italy	AOU Policlinico S.Orsola-Malpighi	Bologna

Sponsors (2)

Lead Sponsor	Collaborator
University of Bologna	SCHARPER Spa

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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 Inflammati — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).		8 weeks