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

Not Applicable

Completed

• Conditions: Hypercholesterolemia
• Interventions: Dietary Supplement: Eufortyn Colesterolo Plus; Dietary Supplement: Placebo

• Registration Number: NCT04574505
• Lead Sponsor: University of Bologna

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-14
• Study First Submitted: 2020-09-14
• Study First Submitted QC: 2020-09-28
• Study First Posted: 2020-10-05
• Primary Completion: 2021-11-19
• Study Completion: 2022-01-19
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-30
• Last Update Posted: 2024-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NUT	Eufortyn Colesterolo Plus	1 tablet of Eufortyn Colesterolo Plus per day + standard diet for 8 weeks
Placebo	Placebo	1 tablet of Placebo per day + standard diet for 8 weeks

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

AOU Policlinico S.Orsola-Malpighi; 🇮🇹 Bologna, Italy