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Completed

NCT Number: NCT06657456

Impact of 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.

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Key information

Conditions

Cholesterol, Elevated Dyslipidemias Hypercholesterolaemia Hypercholesterolemia Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCAM San Antonio Catholic University of Murcia

Murcia, 30107, Spain

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Phytosterol-rich extract

Dietary Supplement

Experimental product: extract rich in phytosterols

Placebo

Dietary Supplement

Product with identical characteristics to the experimental product.

Primary outcomes

  1. Blood lipid profile

    Time frame: Day 1, at 28 and 56 days

    Includes total cholesterol, LDL-cholesterol, HDL-cholesterol and triglycerides

Secondary outcomes

  1. Anthropometric parameters

    Time frame: Day 1, at 28 and 56 days

    Body weight (Kg), body mass index (kg/m^2) and waist circumference (cm)

  2. Body composition measures

    Time frame: Day 1, at 28 and 56 days

    Fat-free mass (Kg) and fat mass (Kg)

  3. Oxidation markers

    Time frame: Day 1, at 28 and 56 days

    Measurement of oxidized LDL

  4. Dietary Intake

    Time frame: Day 1, at 28 and 56 days

    Registration and subsequent nutritional evaluation with 3-day food frequency questionnaire (FFQ).

  5. Adherence to the Mediterranean diet

    Time frame: Day 1, at 28, and 56 days

    Measurement of adherence to the Mediterranean diet by the MEDAS questionnaire.

  6. Blood pressure

    Time frame: Day 1, at 28 and 56 days

    Systolic blood pressure and diastolic blood pressure (mmHg).

  7. Physical Activity

    Time frame: Day 1, at 28 and 56 days

    Measured by IPAQ/GPAQ questionnaire.

  8. Liver safety variables

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Desirée Victoria Montesinos

Other

Collaborators

  • Universidad Católica San Antonio de Murcia

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Oct 24, 2024
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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