Hypercholesterolemia
Conditions
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.
Interventions
DIETARY_SUPPLEMENTEufortyn 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.
DIETARY_SUPPLEMENTPlacebo
Placebo
Sponsors
SCHARPER Spa
University of Bologna
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
This is a two-arm randomized, placebo-controlled, double-blind, monocentric parallel-groups clinical study conducted in Italy.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| 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 |
Countries
Italy
Outcome results
None listed