Clinical trial NCT06403748: Effect of a Dietary Supplement on Lipid Pattern, Indexes of NAFLD and Systemic Inflammation in Healthy Subjects With Suboptimal LDL-C Levels
Official title: Evaluation of the Effect of a Food Supplementation With a Combined Food Supplement on Lipid Pattern, Indexes of NAFLD and Systemic Inflammation in Healthy Subjects With Suboptimal LDL-C Levels: a Two-arm Double-blind, Placebo-controlled, Randomized, Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hypercholesterolemia
Inflammation
Lead sponsor: University of Bologna
Sponsor class: OTHER
First posted: 2024-05-08
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Effect of the dietary supplement on LDL-C at 6-week follow-up
timeFrame: 6 weeks
measure: Effect of the dietary supplement on LDL-C at 6-week follow-up
timeFrame: 12 weeks
Secondary outcomes:
measure: Effect of the dietary supplement on lipid fractions
timeFrame: 12 weeks
measure: Effect of the dietary supplement on apolipoproteins
timeFrame: 12 weeks
measure: Effect of the dietary supplement on hsCRP
timeFrame: 12 weeks
measure: Effect of the dietary supplement on indexes of NAFLD
timeFrame: 12 weeks
measure: Effect of the dietary supplement on waist circumference
timeFrame: 12 weeks
measure: Effect of the dietary supplement on weight
timeFrame: 12 weeks
measure: Effect of the dietary supplement on blood pressure
timeFrame: 12 weeks
measure: Effect of the dietary supplement on creatininemia
timeFrame: 12 weeks
measure: Effect of the dietary supplement on eGFR
timeFrame: 12 weeks
measure: Effect of the dietary supplement on CPK levels
timeFrame: 12 weeks
measure: Tolerability of the dietary supplement
timeFrame: 12 weeks
measure: Acceptability of the dietary supplement
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: University of Bologna
state: BO
Study officials:
References: