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

Primary Purpose

Hypercholesterolemia

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Eufortyn Colesterolo Plus
Placebo
Sponsored by
University of Bologna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypercholesterolemia

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • AOU Policlinico S.Orsola-Malpighi

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

NUT

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
September 14, 2020
Last Updated
July 25, 2022
Sponsor
University of Bologna
Collaborators
SCHARPER Spa
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1. Study Identification

Unique Protocol Identification Number
NCT04574505
Brief Title
Food Supplementation With Eufortyn Colesterolo Plus for LDL Modulation in Subjects With Polygenic Hypercholesterolemia
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
September 14, 2020 (Actual)
Primary Completion Date
November 19, 2021 (Actual)
Study Completion Date
January 19, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Bologna
Collaborators
SCHARPER Spa

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a two-arm randomized, placebo-controlled, double-blind, monocentric parallel-groups clinical study conducted in Italy.
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NUT
Arm Type
Experimental
Arm Description
1 tablet of Eufortyn Colesterolo Plus per day + standard diet for 8 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
1 tablet of Placebo per day + standard diet for 8 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Eufortyn Colesterolo Plus
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
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).
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arrigo Cicero, MD
Organizational Affiliation
University of Bologna
Official's Role
Principal Investigator
Facility Information:
Facility Name
AOU Policlinico S.Orsola-Malpighi
City
Bologna
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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