Hypercholesterolemia, Inflammation
Conditions
Brief summary
The primary purpose of our research will be to evaluate if, in subjects with a low-moderate cardiovascular risk (CV risk\>1% but \< 5%) evidenced by sub-optimal cholesterol levels as per ESC/EAS guidelines (LDL cholesterol \>115 mg/dL, \< 190 mg/dL) supplementation with a food supplement is able to significantly influence plasma lipid levels. Furthermore, the systemic activation status of the inflammatory cascade and the arterial wall stiffness will be investigated.
Interventions
DIETARY_SUPPLEMENTDietary supplement formulated with components of natural origin: artichoke, danshen, bergamot, folic acid, chromium and excipients.
The study will be conducted in male and female subjects, at least 18 and less than 70 years of age, with suboptimal level of LDL-Cholesterol (LDL 115-190 mg/dL) randomized into two groups to receive a preconstituted food supplement (NUT) combination containing (Red yeast rice 160 mg + Berberis aristate 449,7 mg + Folic acid 200 μg and others) in combination with a standard Mediterranean diet at low cholesterol content (\<200 mg/day) (Standard of Care - SOC) \[group 1\], or a PLACEBO in combination with hypo-cholesterol diet (healthy Mediterranean diet following the indication of the European Atherosclerosis Society guidelines) \[group 2\].
OTHERPlacebo
Placebo
Sponsors
University of Bologna
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
The subjects will have to meet all the following inclusion criteria: 1. Subjects agree to participate in the study and having dated and signed the informed consent form. 2. Male or female aged ≥ 18 years and ≤ 70 years old. 3. LDL-Cholesterol plasma levels \>115 mg/dL and \< 190 mg/dL. 4. TG\<400 mg/dL. 5. 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 2012, the intervention strategy does not require a pharmacological lipid- lowering intervention. 6. Subjects who have the capability to communicate, to make themselves understood, and to comply with the study's requirements.
Exclusion criteria
Subjects fulfilling one or more of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect of the dietary supplement on LDL-C at 6-week follow-up | 6 weeks | The primary objective is to compare the effect on LDL-C after 6 weeks of treatment with a combined food supplement compared to placebo (standard diet only). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effect of the dietary supplement on apolipoproteins | 12 weeks | Evaluate the effect of the tested combined food supplement intake on changes in apolipoproteins |
| Effect of the dietary supplement on hsCRP | 12 weeks | Evaluate the effect of the tested combined food supplement intake on hsCRP levels |
| Effect of the dietary supplement on indexes of NAFLD | 12 weeks | Evaluate the effect of the tested combined food supplement intake on validated indexes of non-alcoholic fatty liver disease |
| Effect of the dietary supplement on waist circumference | 12 weeks | Evaluate the effect of the tested food supplement intake on changes in waist circumference. Waist circumference will be measured in a horizontal plane at the end of a normal expiration, at the midpoint between the inferior margin of the last rib and the superior iliac crest. |
| Effect of the dietary supplement on weight | 12 weeks | Evaluate the effect of the tested food supplement intake on changes in weight. Weight will be measured to the nearest 0.1 Kg. |
| Effect of the dietary supplement on lipid fractions | 12 weeks | Evaluate the effect of the tested combined food supplement intake on changes in other lipid fractions |
| Effect of the dietary supplement on creatininemia | 12 weeks | Evaluate the effect of the tested food supplement intake on changes in creatininemia |
| Effect of the dietary supplement on eGFR | 12 weeks | Evaluate the effect of the tested food supplement intake on renal function, evaluated as eGFR |
| Effect of the dietary supplement on CPK levels | 12 weeks | Evaluate the effect of the tested food supplement intake on changes in the blood levels of CPK |
| Tolerability of the dietary supplement | 12 weeks | Comparative evaluation of the short-term tolerability of the tested food supplement. Tolerability will be evaluated through a continuous monitoring during the study, to detect any adverse event, clinical safety, laboratory findings, vital sign measurements, and physical examinations |
| Acceptability of the dietary supplement | 12 weeks | Comparative evaluation of the short-term acceptability of the tested food. Acceptability will be evaluated by the use of a 10-point hedonic scale, where 1 = Disliked extremely and 9 = Liked extremely. |
| Effect of the dietary supplement on blood pressure | 12 weeks | Evaluate the effect of the tested food supplement intake on changes in systolic blood pressure and diastolic blood pressure |
Countries
Italy
Outcome results
None listed