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

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.

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.

Study Overview

• Status: Completed
• Conditions: Hypercholesterolemia
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Eufortyn Colesterolo Plus

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Bologna, Italy
    • AOU Policlinico S.Orsola-Malpighi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NUT; 1 tablet of Eufortyn Colesterolo Plus per day + standard diet for 8 weeks	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 Comparator: Placebo; 1 tablet of Placebo per day + standard diet for 8 weeks	Dietary supplement: Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Bologna
• Collaborators: SCHARPER Spa
• Investigators: Principal Investigator: Arrigo Cicero, MD, University of Bologna

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2020
• Primary Completion (Actual): November 19, 2021
• Study Completion (Actual): January 19, 2022

Study Registration Dates

• First Submitted: September 14, 2020
• First Submitted That Met QC Criteria: September 28, 2020
• First Posted (Actual): October 5, 2020

Study Record Updates

• Last Update Posted (Estimated): February 1, 2024
• Last Update Submitted That Met QC Criteria: January 30, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Hypercholesterolemia
• Other Study ID Numbers: SCH 01/2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No