NCT06403748Not yet recruitingNot Applicable
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
University of Bologna2 sites in 1 country90 target enrollmentStarted: May 6, 2024Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 90
- Locations
- 2
- Primary Endpoint
- Effect of the dietary supplement on LDL-C at 6-week follow-up
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Effect of the dietary supplement on LDL-C at 6-week follow-up
Time Frame: 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 Outcomes
- Effect of the dietary supplement on lipid fractions(12 weeks)
- Effect of the dietary supplement on indexes of NAFLD(12 weeks)
- Effect of the dietary supplement on weight(12 weeks)
- Effect of the dietary supplement on blood pressure(12 weeks)
- Effect of the dietary supplement on eGFR(12 weeks)
- Effect of the dietary supplement on waist circumference(12 weeks)
- Tolerability of the dietary supplement(12 weeks)
- Effect of the dietary supplement on creatininemia(12 weeks)
- Effect of the dietary supplement on apolipoproteins(12 weeks)
- Effect of the dietary supplement on hsCRP(12 weeks)
- Effect of the dietary supplement on CPK levels(12 weeks)
- Acceptability of the dietary supplement(12 weeks)
Investigators
Claudio Borghi
Prof. Dr.
University of Bologna
Study Sites (2)
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