RECRUITINGINTERVENTIONAL
Plant Sterols on Cardiovascular Markers, Microbiota and Sterol Metabolism (Cardiofoodsterol)
Effect of Plant Sterols on Inflammatory, Endothelial Function and Oxidative Stress Markers, Microbiota and Sterol Metabolism in a Cardiovascular Risk Population
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- 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
- Serum levels of biochemical and hematological parameters and fat-soluble vitamins within reference ranges.
Who Should NOT Join This Trial:
- Subjects on cholesterol-lowering pharmacological treatment
- Smokers
- Alcohol consumption above 30 g/day
- Pregnant or lactating women
- Any infection, serious illness or co-morbidity that may affect the bioavailability of PS (e.g., malabsorption, celiac disease, allergies or food intolerances)
- Diseases of the gastrointestinal tract
- Antibiotic, hormonal or anabolic treatment
- Participants consuming foods enriched with PS or food supplements that contain PS
- Participants who follow specialist weight loss diets, vegans or vegetarians
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
* 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
* Serum levels of biochemical and hematological parameters and fat-soluble vitamins within reference ranges.
Exclusion Criteria:
* Subjects on cholesterol-lowering pharmacological treatment
* Smokers
* Alcohol consumption above 30 g/day
* Pregnant or lactating women
* Any infection, serious illness or co-morbidity that may affect the bioavailability of PS (e.g., malabsorption, celiac disease, allergies or food intolerances)
* Diseases of the gastrointestinal tract
* Antibiotic, hormonal or anabolic treatment
* Participants consuming foods enriched with PS or food supplements that contain PS
* Participants who follow specialist weight loss diets, vegans or vegetarians
Treatments Being Tested
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
Locations (1)
Hospital Universitario y Politécnico La Fe de Valencia
Valencia, Spain