Effect of a Dietary Supplement on Lipid Pattern, Indexes of NAFLD and Systemic Inflammation in Healthy Subjects With Suboptimal LDL-C Levels

University of Bologna90 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Hypercholesterolemia Inflammation

Interventions

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) \[group 2\].

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 exclusion criteria will not be included in the study: 1. Subjects already affected by cardiovascular diseases (secondary prevention) or with estimated 10 years cardiovascular disease risk \> 5%; 2. Obesity (BMI\>30 kg/m2) or diabetes mellitus; 3. Assumption of lipid-lowering drugs or food supplements, or drugs potentially affecting the lipid metabolism; 4. Antihypertensive treatment not stabilized for at least 3 months; 5. Anticoagulant therapy 6. Uncontrolled hypertension (systolic blood pressure\> 190 mmHg or diastolic arterial pressure\> 100 mmHg); 7. Known current thyroid, gastrointestinal or hepatobiliary diseases; 8. Any medical or surgical condition that would limit the participant adhesion to the study protocol; 9. Abuse of alcohol or drugs (current or previous); 10. History of malignant neoplasia in the 5 years prior to enrolment in the study; 11. History or clinical evidence of inflammatory diseases such as severe arthritis, systemic lupus erythematosus or chronic inflammatory diseases or current therapy with immunosuppressive agents or long-term glucocorticoids; 12. History or clinical evidence of any significant concomitant disease that could compromise the safety of the subject or the possibility of completing the study; 13. Known previous intolerance to one component of the tested nutraceuticals or to one of these plant species: Asteraceae or Compositae; 14. Women in fertile age not using consolidated contraceptive methods 15. Pregnancy and Breastfeeding.

Outcomes

Primary Outcomes

Effect of the dietary supplement on LDL-C at 6-week follow-up

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).

Time frame: 6 weeks

Effect of the dietary supplement on LDL-C at 6-week follow-up

The primary objective is to compare the effect on LDL-C after 12 weeks of treatment with a combined food supplement compared to placebo (standard diet only).

Time frame: 12 weeks

Secondary Outcomes

Effect of the dietary supplement on lipid fractions

Evaluate the effect of the tested combined food supplement intake on changes in other lipid fractions

Time frame: 12 weeks

Effect of the dietary supplement on apolipoproteins

Evaluate the effect of the tested combined food supplement intake on changes in apolipoproteins

Time frame: 12 weeks

Effect of the dietary supplement on hsCRP

Evaluate the effect of the tested combined food supplement intake on hsCRP levels

Time frame: 12 weeks

Effect of the dietary supplement on indexes of NAFLD

Evaluate the effect of the tested combined food supplement intake on validated indexes of non-alcoholic fatty liver disease

Time frame: 12 weeks

Effect of the dietary supplement on waist circumference

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.

Time frame: 12 weeks

Effect of the dietary supplement on weight

Evaluate the effect of the tested food supplement intake on changes in weight. Weight will be measured to the nearest 0.1 Kg.

Time frame: 12 weeks

Effect of the dietary supplement on blood pressure

Evaluate the effect of the tested food supplement intake on changes in systolic blood pressure and diastolic blood pressure

Time frame: 12 weeks

Effect of the dietary supplement on creatininemia

Evaluate the effect of the tested food supplement intake on changes in creatininemia

Time frame: 12 weeks

Effect of the dietary supplement on eGFR

Evaluate the effect of the tested food supplement intake on renal function, evaluated as eGFR

Time frame: 12 weeks

Effect of the dietary supplement on CPK levels

Evaluate the effect of the tested food supplement intake on changes in the blood levels of CPK

Time frame: 12 weeks

Tolerability of the dietary supplement

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

Time frame: 12 weeks

Acceptability of the dietary supplement

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.

Time frame: 12 weeks

Effect of a Dietary Supplement on Lipid Pattern, Indexes of NAFLD and Systemic Inflammation in Healthy Subjects With Suboptimal LDL-C Levels

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes