Evaluation of Food Supplementation in Subjects With Suboptimal Levels of LDL Cholesterol (NCT07492264) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of Food Supplementation in Subjects With Suboptimal Levels of LDL Cholesterol
Italy90 participantsStarted 2020-02-21
Plain-language summary
This randomized, double-blind, placebo-controlled, parallel-group clinical study aims to evaluate the effect of a dietary supplement on LDL-cholesterol levels in healthy adults with suboptimal LDL-C values. Eligible participants will follow standard dietary recommendations based on the Mediterranean diet, according to the European Atherosclerosis Society guidelines. Subjects will be randomized to receive either the dietary supplement (1 tablet/day) or placebo (1 tablet/day), both in combination with dietary recommendations, over a treatment period of 12 weeks.
The primary objective is to compare the effect of the tested food supplement versus placebo on LDL-cholesterol after 12 weeks of treatment. Secondary objectives include evaluating changes in LDL-cholesterol at 6 weeks, other lipid fractions, homocysteine, glucose and insulin levels, hsCRP, anthropometric parameters, as well as tolerability and acceptability of the supplement. Safety will be assessed through the collection of adverse events.
Study participation lasts approximately 16 weeks, including screening, diet stabilization run-in, treatment, and follow-up assessments. Outcome measures will be collected at baseline, after 6 weeks, and after 12 weeks of treatment.
Who can participate
Age range18 Years – 70 Years
SexALL
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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 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.
✓. Patient covered by the Social Security scheme.
✓. Pregnancy test.
Exclusion criteria
✕. Subjects already affected by cardiovascular diseases (secondary prevention) or with estimated 10 years cardiovascular disease risk\> 5%;