Impact of Phytosterol-Rich Extract on Lipid Profile

Not Applicable

Active, not recruiting

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

• Registration Number: NCT06657456
• Lead Sponsor: Desirée Victoria Montesinos

Brief Summary

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.

Detailed 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).

Study Timeline

• Study First Submitted: 2024-10-19
• Study First Submitted QC: 2024-10-23
• Study First Posted: 2024-10-24
• Study Start: 2025-01-08
• Primary Completion: 2025-04-10
• Status Verified: 2025-05
• Study Completion: 2025-05
• Last Update Submitted: 2025-05-20
• Last Update Posted: 2025-05-21

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 42

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Blood lipid profile	Day 1, at 28 and 56 days	Includes total cholesterol, LDL-cholesterol, HDL-cholesterol and triglycerides

Secondary Outcome Measures

Name	Time	Method
Oxidation markers	Day 1, at 28 and 56 days	Measurement of oxidized LDL
Anthropometric parameters	Day 1, at 28 and 56 days	Body weight (Kg), body mass index (kg/m\^2) and waist circumference (cm)
Body composition measures	Day 1, at 28 and 56 days	Fat-free mass (Kg) and fat mass (Kg)
Dietary Intake	Day 1, at 28 and 56 days	Registration and subsequent nutritional evaluation with 3-day food frequency questionnaire (FFQ).
Adherence to the Mediterranean diet	Day 1, at 28, and 56 days	Measurement of adherence to the Mediterranean diet by the MEDAS questionnaire.
Blood pressure	Day 1, at 28 and 56 days	Systolic blood pressure and diastolic blood pressure (mmHg).
Physical Activity	Day 1, at 28 and 56 days	Measured by IPAQ/GPAQ questionnaire.
Liver safety variables	Day 1, at 28 and 56 days	It is a blood test that measures liver enzymes, such as GPT (ALT) and GOT (AST), to evaluate liver function.

Trial Locations

Locations (1)

UCAM San Antonio Catholic University of Murcia; 🇪🇸 Murcia, Spain