Impact of Phytosterol-Rich Extract on Lipid Profile
April 28, 2026 updated by: Desirée Victoria Montesinos
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.
Study Overview
Status
Completed
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
42
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Murcia
-
Murcia, Murcia, Spain, 30107
- UCAM San Antonio Catholic University of Murcia
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental
Consumption of dietary supplement capsules for 56 days.
|
Experimental product: extract rich in phytosterols
|
|
Placebo Comparator: Control Group
Identically appearing placebo capsules consumed for 56 days.
|
Product with identical characteristics to the experimental product.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Blood lipid profile
Time Frame: Day 1, at 28 and 56 days
|
Includes total cholesterol, LDL-cholesterol, HDL-cholesterol and triglycerides
|
Day 1, at 28 and 56 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Anthropometric parameters
Time Frame: Day 1, at 28 and 56 days
|
Body weight (Kg), body mass index (kg/m^2) and waist circumference (cm)
|
Day 1, at 28 and 56 days
|
|
Body composition measures
Time Frame: Day 1, at 28 and 56 days
|
Fat-free mass (Kg) and fat mass (Kg)
|
Day 1, at 28 and 56 days
|
|
Oxidation markers
Time Frame: Day 1, at 28 and 56 days
|
Measurement of oxidized LDL
|
Day 1, at 28 and 56 days
|
|
Dietary Intake
Time Frame: Day 1, at 28 and 56 days
|
Registration and subsequent nutritional evaluation with 3-day food frequency questionnaire (FFQ).
|
Day 1, at 28 and 56 days
|
|
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.
|
Day 1, at 28, and 56 days
|
|
Blood pressure
Time Frame: Day 1, at 28 and 56 days
|
Systolic blood pressure and diastolic blood pressure (mmHg).
|
Day 1, at 28 and 56 days
|
|
Physical Activity
Time Frame: Day 1, at 28 and 56 days
|
Measured by IPAQ/GPAQ questionnaire.
|
Day 1, at 28 and 56 days
|
|
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.
|
Day 1, at 28 and 56 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Desirée Victoria Montesinos, Universidad Católica San Antonio de Murcia
- Principal Investigator: Ana Mª García Muñoz, Universidad Católica San Antonio de Murcia
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 8, 2025
Primary Completion (Actual)
April 10, 2025
Study Completion (Actual)
May 30, 2025
Study Registration Dates
First Submitted
October 19, 2024
First Submitted That Met QC Criteria
October 23, 2024
First Posted (Actual)
October 24, 2024
Study Record Updates
Last Update Posted (Actual)
May 4, 2026
Last Update Submitted That Met QC Criteria
April 28, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CE102401
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.