NCT06954649

Brief Summary

The aim of this clinical trial is to evaluate the functionality of an extract rich in phytosterols and phytostanols on parameters related to the lipid profile of individuals with hypercholesterolemia, mainly on total cholesterol and LDL cholesterol levels

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 14, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 24, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 27, 2025

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

April 24, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 1, 2025

Completed
Last Updated

May 1, 2025

Status Verified

April 1, 2025

Enrollment Period

1 month

First QC Date

April 24, 2025

Last Update Submit

April 24, 2025

Conditions

Cholesterol LoweringLDL Level

Keywords

cholesterolLDLHDLoxidized LDLtriglyceridesphytosterolsbioactive compoundsresveratrolhydroxytosol

Outcome Measures

Primary Outcomes (6)

  • Total cholesterol

    Change from baseline in total cholesterol levels measured at 28 and 56 days

    From enrollment to the end of treatment at 56 days

  • Cholesterol LDL

    Change from baseline in cholesterol LDL levels measured at 28 and 56 days

    From enrollment to the end of treatment at 56 days

  • Cholesterol HDL

    Change from baseline in cholesterol HDL levels measured at 28 and 56 days

    From enrollment to the end of treatment at 56 days

  • Triglyceride

    Change from baseline in triglyceride levels measured at 28 days and 56 days

    From enrollment to the end of treatment at 56 days

  • Transaminase

    Change from baseline in transaminase levels measured at 28 days and 56 days

    From enrollment to the end of treatment at 56 days

  • Oxidized LDL

    Change from baseline in oxidized LDL levels measured at 28 and 56 days

    From enrollment to the end of treatment at 56 days

Study Arms (2)

Treatment group

EXPERIMENTAL

Experimental group. They will take an extract rich in phytosterols and phytostanols, resveratrol and hydroxytyrosol. They will take two capsules of the extract in the evening after dinner.

Dietary Supplement: Plant based extract rich in phytosterols and phytostanols resveratrol and hydroxytyrosol.

Placebo group

PLACEBO COMPARATOR

Control group. They will take a placebo supplement. They will take two capsules of the placebo, in the evening after dinner.

Other: Placebo

Interventions

Plant based extract rich in phytosterols and phytostanols resveratrol and hydroxytyrosol.DIETARY_SUPPLEMENT

Individuals will take two capsules daily of the phytosterol-rich extract for 56 days. Two capsules will be taken daily in the evening, after dinner

Treatment group
PlaceboOTHER

Individuals will take two capsules daily of the placebo capsule for 56 days. Two capsules will be taken daily in the evening, after dinner

Placebo group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centro de Edafología y Biología Aplicada del Segura (CEBAS-CSIC)

Murcia, 30100, Spain

Location

Universidad Católica San Antonio de Murcia (UCAM)

Murcia, 30107, Spain

Location

MeSH Terms

Interventions

Phytosterols3,4-dihydroxyphenylethanol

Intervention Hierarchy (Ancestors)

SterolsCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsMembrane LipidsLipidsPhytochemicalsBiological Factors

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Clinical trial organizer (Universidad Católica San Antonio de Murcia, UCAM)
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Professor

Study Record Dates

First Submitted

April 24, 2025

First Posted

May 1, 2025

Study Start

January 14, 2025

Primary Completion

February 24, 2025

Study Completion

March 27, 2025

Last Updated

May 1, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

ES(2)