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NCT Number: NCT06247137

Effect of a Food Supplementation With a Combined Food Supplement on Lipid Pattern, Indexes of Non-alcoholic Fatty Liver Disease and Systemic Inflammation

Several controlled interventional studies have shown that there is a close correlation between cholesterol reduction and cardiovascular risk; in fact, reductions in serum levels of total cholesterol and low-density lipoprotein cholesterol (LDL-C), obtained through lifestyle modification or specific drugs, result in reductions in the incidence of major coronary events. The effectiveness of these interventions has been demonstrated both in subjects in primary prevention and in subjects in secondary prevention.

Based on this evidence, the National Cholesterol Education Program (NCEP) has defined in the ATP III report the target values of LDL-C to be reached with interventions on food and / or pharmacological habits to perform an effective cardiovascular prevention.

Although the atherogenic action of hypercholesterolemia is largely attributable to a direct damage exerted on vascular endothelium, recent studies suggest that the activation of a low-grade systemic pro-inflammatory state, typical of the patient with cardiovascular risk factors, does also play a role in the determinism of endothelial damage and atheroma degeneration of the arteries. It is believed that this systemic inflammation, as documented by the determination of some humoral signs of inflammation (e.g. C-reactive protein, interleukin-6, tumor necrosis factor-α), may further contribute to an increase of cardiovascular risk.

The inflammatory state can modulate the atherosclerotic process at various levels, determining endothelial activation, promoting leukocyte chemotaxis in the sub-intimal space of the arterial wall and therefore the formation of an atheromatous plaque rich in inflammatory cells; the latter represents the lesion responsible for the vast majority of the coronary and cerebrovascular events observed in subjects with cardiovascular risk factors.

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Key information

Conditions

Hypercholesterolemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Bologna

Bologna, BO, 40138, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects agree to participate in the study and having dated and signed the informed consent form.
  • Subjects who have the capability to communicate, to make themselves understood, and to comply with the study's requirements.
  • Male or female aged ≥ 18 years and ≤ 70 years old.
  • LDL-Cholesterol blood 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.
  • Patient covered by the Social Security scheme.

Exclusion criteria

  • 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 since at least 3 months;
  • Anticoagulants 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 patient 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 disease 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
  • Women in fertile age not using consolidated contraceptive methods
  • Pregnancy and Breastfeeding.

Treatment and study plan

Dietary Supplement

Dietary Supplement

Dietary supplement formulated with components of natural origin: artichoke, bergamot, folic acid, astaxanthin, Chromium picolinate and excipients.

Oral administration: 1 tablet/day at evening meal

Placebo

Other

Placebo (microcrystalline cellulose, calcium carbonate, magnesium stearate, silica dioxide and iron oxides).

Oral administration: 1 tablet/day at evening meal.

Primary outcomes

  1. LDL-cholesterolemia reduction from baseline and between groups

    Time frame: 3 months

    Reduction of LDL-cholesterolemia after 3 months of treatment

Secondary outcomes

  1. LDL-cholesterolemia reduction from baseline and between groups at 6 weeks

    Time frame: 6 weeks

    Reduction of LDL-cholesterolemia after 6 weeks of treatment

  2. Changes in hsCRP

    Time frame: 3 months

    Evaluate the effect of the dietary supplementation on blood levels of hsCRP after 3 months of treatment

  3. Change in vascular reactivity

    Time frame: 3 months

    Evaluate the effect of the dietray supplementation on the vascular reactivity (Endocheck®)

Sponsors and collaborators

Lead sponsor

University of Bologna

Other

Registry information

Official study title

Evaluation of the Effect of a Food Supplementation With a Combined Food Supplement on Lipid Pattern, Indexes of Non-alcoholic Fatty Liver Disease and Systemic Inflammation in Healthy Subjects With Suboptimal LDL-C Levels: a Two-arm Double-blind, Placebo- Controlled, Randomized, Clinical Trial

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 7, 2024
Registry last updated
Apr 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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