Effect of a Dietary Supplement on Lipid Pattern, Indexes of NAFLD and Systemic Inflammation in Healthy Subjects With Suboptimal LDL-C Levels
- Conditions
- HypercholesterolemiaInflammation
- Interventions
- Other: Placebo
- Registration Number
- NCT06403748
- Lead Sponsor
- University of Bologna
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 90
The subjects will have to meet all the following inclusion criteria:
- Subjects agree to participate in the study and having dated and signed the informed consent form.
- 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 2012, the intervention strategy does not require a pharmacological lipid- lowering intervention.
- Subjects who have the capability to communicate, to make themselves understood, and to comply with the study's requirements.
Subjects fulfilling one or more of the following exclusion criteria will not be included in the study:
- 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 for at least 3 months;
- Anticoagulant 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 participant 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 diseases 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 or to one of these plant species: Asteraceae or Compositae;
- Women in fertile age not using consolidated contraceptive methods
- Pregnancy and Breastfeeding.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo -
- Primary Outcome Measures
Name Time Method Effect of the dietary supplement on LDL-C at 6-week follow-up 12 weeks 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).
- Secondary Outcome Measures
Name Time Method 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 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 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 blood pressure 12 weeks Evaluate the effect of the tested food supplement intake on changes in systolic blood pressure and diastolic blood pressure
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 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.
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
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 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 CPK levels 12 weeks Evaluate the effect of the tested food supplement intake on changes in the blood levels of CPK
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.
Trial Locations
- Locations (1)
University of Bologna
🇮🇹Bologna, BO, Italy