Plant Sterols on Cardiovascular Markers, Microbiota and Sterol Metabolism (Cardiofoodsterol)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of Valencia
About this trial
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.
Eligibility criteria
Qualifiers
BMI: 27-29.9 or 30-39.9
Plasmatic glucose: < 100mg/dl or 100-125mg/dl
Glycosylated hemoglobin: < 5.7 or 5.7-6.4
LDL cholesterol > 115mg/dL
Disqualifiers
Subjects on cholesterol-lowering pharmacological treatment
Smokers
Alcohol consumption above 30 g/day
Pregnant or lactating women
Trial design
Treatments tested in this trial
- Plant sterols 2g/day
- Placebo
Treatment groups
42 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Valencia
Lead sponsor
Hospital Universitario La Fe
Collaborator
University of Bologna
Collaborator
Source ClinicalTrials.gov