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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
90
Colledoro Medical Center
Siena, Siena, Italy
Effect on LDL Cholesterol
Time frame: 12 weeks
Effect on LDL Cholesterol
Time frame: 6 weeks
Effect on Total Cholesterol
Time frame: 12 weeks
Effect on Total Cholesterol
Time frame: 6 weeks
Effect on HDL Cholesterol
Time frame: 12 weeks
Effect on HDL Cholesterol
Time frame: 6 weeks
Effect on Tryglicerides
Time frame: 12 weeks
Effect on Tryglicerides
Time frame: 6 weeks
Effect on Homocysteine
Time frame: 12 weeks
Effect on Homocysteine
Time frame: 6 weeks
Effect on Glycaemia
Time frame: 12 weeks
Effect on Glycaemia
Time frame: 6 weeks
Effect on Insulin
Time frame: 12 weeks
Effect on Insulin
Time frame: 6 weeks
Effect on Body Weight
Time frame: 12 weeks
Effect on Body Weight
Time frame: 6 weeks
Effect on Waist Circumference
Time frame: 12 weeks
Effect on Waist Circumference
Time frame: 6 weeks
Effect on Blood Pressure
Time frame: 12 weeks
Effect on Blood Pressure
Time frame: 6 weeks
Effect on hsCRP
Time frame: 12 weeks
Effect on hsCRP
Time frame: 6 weeks
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