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
This trial does not accept healthy volunteersQualifiers
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
Design model
Crossover
Treatments tested in this trial
Plant sterols 2g/day
Dietary supplementPS-containing dietary supplement Sachet containing a powdered microencapsulated free plant sterols (2 g ingredient/day) during 8 weeks
Placebo
Dietary supplementSachet containing the powdered excipients of the dietary supplement during 8 weeks
Treatment groups
42 Participants
are divided into 2 treatment groupsGroup A: Dietary SupplementExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Changes in plasmatic LDL-c
LDL-c, calculated by the Friedewald's formula, with repeated measures (at the beginning and at the end of each period the intervention)
Time frame
0, 8, 14 and 22 weeksSecondary outcomes
1
Changes in plasmatic total cholesterol
Total cholesterol, assessed by enzymatic-colorimetric methods, with repeated measures (at the beginning and at the end of each period the intervention)
Time frame
0, 8, 14 and 22 weeks2
Changes in plasmatic HDL-c
HDL-c, assessed by enzymatic-colorimetric methods, with repeated measures (at the beginning and at the end of each period the intervention)
Time frame
0, 8, 14 and 22 weeks3
Changes in plasmatic non-HDL cholesterol
Non-HDL cholesterol, calculated by subtracting HDL-c from total cholesterol, with repeated measures (at the beginning and at the end of each period the intervention)
Time frame
0, 8, 14 and 22 weeks4
Changes in plasmatic triglycerides
Triglycerides, assessed by enzymatic-colorimetric methods, with repeated measures (at the beginning and at the end of each period the intervention)
Time frame
0, 8, 14 and 22 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Valencia
Lead sponsor
Hospital Universitario La Fe
Collaborator
University of Bologna
Collaborator
Source ClinicalTrials.gov