Impact of Phytosterol-Rich Extract on Lipid Profile
Nutritional Intervention Study of the Effect of a Phytosterol-rich Extract on Lipid Profile.
1 other identifier
interventional
42
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2025
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 19, 2024
CompletedFirst Posted
Study publicly available on registry
October 24, 2024
CompletedStudy Start
First participant enrolled
January 8, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 10, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2025
CompletedMay 4, 2026
April 1, 2026
3 months
October 19, 2024
April 28, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Blood lipid profile
Includes total cholesterol, LDL-cholesterol, HDL-cholesterol and triglycerides
Day 1, at 28 and 56 days
Secondary Outcomes (8)
Anthropometric parameters
Day 1, at 28 and 56 days
Body composition measures
Day 1, at 28 and 56 days
Oxidation markers
Day 1, at 28 and 56 days
Dietary Intake
Day 1, at 28 and 56 days
Adherence to the Mediterranean diet
Day 1, at 28, and 56 days
- +3 more secondary outcomes
Study Arms (2)
Experimental
EXPERIMENTALConsumption of dietary supplement capsules for 56 days.
Control Group
PLACEBO COMPARATORIdentically appearing placebo capsules consumed for 56 days.
Interventions
Experimental product: extract rich in phytosterols
Product with identical characteristics to the experimental product.
Eligibility Criteria
You may qualify if:
- Adults (age \> 18 YO)
- Total cholesterol levels at screening ≥ 200 mg/dL
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UCAM San Antonio Catholic University of Murcia
Murcia, Murcia, 30107, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Desirée Victoria Montesinos
Universidad Católica San Antonio de Murcia
- PRINCIPAL INVESTIGATOR
Ana Mª García Muñoz
Universidad Católica San Antonio de Murcia
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 19, 2024
First Posted
October 24, 2024
Study Start
January 8, 2025
Primary Completion
April 10, 2025
Study Completion
May 30, 2025
Last Updated
May 4, 2026
Record last verified: 2026-04