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

RECRUITINGN/ASponsored by University of Valencia
Actively Recruiting
PhaseN/A
SponsorUniversity of Valencia
Started2024-05-21
Est. completion2024-12
Eligibility
Age18 Years – 80 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT06481020

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.

Eligibility

Age: 18 Years – 80 YearsHealthy volunteers accepted
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

Conditions5

Cardiovascular DiseasesDiabetesHypercholesterolemiaOverweight and ObesityPrediabetic State

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