Impact of Phytosterol-Rich Extract on Lipid Profile

Nutritional Intervention Study of the Effect of a Phytosterol-rich Extract on Lipid Profile.

The aim of this randomized, parallel, two-arm, placebo-controlled, triple-blind clinical trial is to evaluate the efficacy of a phytosterol- and phytostanol-rich extract on lipid profile parameters in individuals with hypercholesterolemia, focusing primarily on total cholesterol and LDL cholesterol levels.

The duration of the study will be 56 days during which the investigational product or placebo will be consumed according to the assignment.

Subjects will be randomized to each of the study arms (consumption of the experimental product or control product).

Inclusion Criteria:

• Adults (age > 18 YO)
• Total cholesterol levels at screening ≥ 200 mg/dL

Exclusion Criteria:

• History of allergic hypersensitivity or poor tolerance to any component of the products under study.
• Use of prescribed medication which may interfere with study measurements.
• Unwillingness or inability to comply with clinical trial procedures.
• Subjects whose condition makes them ineligible for the study at the investigator's discretion.
• Pregnant or having the wish to become pregnant, or lactating.
• Recent participation in another nutritional or medical trial