Impact of Phytosterol-Rich Extract on Lipid Profile

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

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06657456

Enrollment

Registered

2024-10-24

Start date

2025-01-08

Completion date

2025-05-30

Last updated

2026-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cholesterol, Elevated, Dyslipidemias, Hypercholesterolaemia, Lipid Metabolism Disorders

Keywords

Cholesterol, Cholesterol, Elevated, Hypercholesterolaemia, Lipid Metabolism Disorders, Dyslipidemias

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).

Interventions

DIETARY_SUPPLEMENTPhytosterol-rich extract

Experimental product: extract rich in phytosterols

DIETARY_SUPPLEMENTPlacebo

Product with identical characteristics to the experimental product.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Blood lipid profile	Day 1, at 28 and 56 days	Includes total cholesterol, LDL-cholesterol, HDL-cholesterol and triglycerides

Secondary

Measure	Time frame	Description
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)
Oxidation markers	Day 1, at 28 and 56 days	Measurement of oxidized LDL
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.

Countries

Spain

Contacts

PRINCIPAL_INVESTIGATORDesirée Victoria Montesinos

Universidad Católica San Antonio de Murcia

PRINCIPAL_INVESTIGATORAna Mª García Muñoz