Impact of Phytosterol-Rich Extract on Lipid Profile

Desirée Victoria Montesinos

Status: Active, not recruiting

Conditions: Cholesterol, Elevated; Dyslipidemias; Lipid Metabolism Disorders; Hypercholesterolaemia

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Phytosterol-rich extract

Study type: Interventional

Funder types: Other

Identifiers

NCT06657456

CE102401

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 42 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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42 participants in 2 patient groups, including a placebo group

Experimental

Experimental group

Description:

Consumption of dietary supplement capsules for 56 days.

Treatment:

Dietary Supplement: Phytosterol-rich extract

Control Group

Placebo Comparator group

Description:

Identically appearing placebo capsules consumed for 56 days.

Treatment:

Dietary Supplement: Placebo