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Plant Sterols on Cardiovascular Markers, Microbiota and Sterol Metabolism (Cardiofoodsterol)

NCT06481020 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2024-07-01

No results posted yet for this study

Summary

Potential cholesterol-lowering effect of a regular intake of a plant sterol (PS)-containing food supplement, in overweight/obese type 1 or 2, normoglycemic/pre-diabetic, with LDL-cholesterol values \> 115 mg/dl and not pharmacologically treated participants treated with the PS-containing food supplement or placebo supplement.

Conditions

Interventions

DIETARY_SUPPLEMENT

Plant sterols 2g/day

PS-containing dietary supplement Sachet containing a powdered microencapsulated free plant sterols (2 g ingredient/day) during 8 weeks

DIETARY_SUPPLEMENT

Placebo

Sachet containing the powdered excipients of the dietary supplement during 8 weeks

Sponsors & Collaborators

  • Hospital Universitario La Fe

    collaborator OTHER

  • University of Bologna

    collaborator OTHER

  • University of Valencia

    lead OTHER

Principal Investigators

  • Guadalupe Garcia Llatas, Professor · University of Valencia

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-21
Primary Completion
2024-12-31
Completion
2025-02-28

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06481020 on ClinicalTrials.gov