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

NCT04574505 | Completed

• 1 other identifier: SCH 01/2020
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

NUT

EXPERIMENTAL

1 tablet of Eufortyn Colesterolo Plus per day + standard diet for 8 weeks

Dietary Supplement: Eufortyn Colesterolo Plus

Placebo

PLACEBO COMPARATOR

1 tablet of Placebo per day + standard diet for 8 weeks

Dietary Supplement: Placebo

Interventions

Eufortyn Colesterolo Plus DIETARY_SUPPLEMENT

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.

NUT

Placebo DIETARY_SUPPLEMENT

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Bologna: lead
• SCHARPER Spa: collaborator

Study Sites (1)

AOU Policlinico S.Orsola-Malpighi

Bologna, Italy

Location

Related 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 Inflammation in Healthy Subjects with Polygenic Hypercholesterolemia: The ANEMONE Study. Nutrients. 2022 May 18;14(10):2099. doi: 10.3390/nu14102099.

  PMID: 35631240 RESULT

MeSH Terms

Conditions

Hypercholesterolemia

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Arrigo Cicero, MD

  University of Bologna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

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

Study Record Dates

• First Submitted: September 14, 2020
• First Posted: October 5, 2020
• Study Start: September 14, 2020
• Primary Completion: November 19, 2021
• Study Completion: January 19, 2022
• Last Updated: February 1, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)