Hypocholesterolemic Effect of a Phytosterol-enriched Spreadable Cream Prepared With Virgin Olive Oil
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional

Summary: 
      This study aims to evaluate the effect of the enriched extra virgin olive oil spread in plant
      sterols from the olive itself and demonstrate its effect anticholesterolemic and
      cardioprotective in children and adolescents with hypercholesterolemia.
    

Detailed description: 
      A clinical study of nutritional intervention, randomized with double blind, adjusted by
      randomization blocks that consider age and sex, and crossover of 2 months duration each
      period, with 1-month washout period, in 50 subjects (25 per randomization group). The study
      will be carried out in the Reina Sofía Universitary Hospital of Córdoba, as well as at the
      Institute of Nutrition and Food Technology of the University of Granada.

      The effects of the enriched spread in patients on the lipid profile will be evaluated plasma
      and its action on biomarkers of cardiovascular risk and on the microbiota intestinal
      depending on the specific genotype of each subject. In addition, the presence of minor olive
      oil compounds present in plasma (metabolomic analysis). In this way, at the end of the
      project, scientific information will be available contrasted on the enriched product and its
      effects on cardiovascular protection, in addition to its palatability and acceptance.

      The main objective is to evaluate the effect of the enriched extra virgin olive oil spread in
      plant sterols from the olive itself and demonstrate its effect anticholesterolemic and
      cardioprotective in children and adolescents with hypercholesterolemia.

      As specific objectives will be determined:

        -  To evaluate the effect of the enriched spread on the plasmatic concentrations of total
           cholesterol, LDLc and other parameters of the lipid profile

        -  To evaluate the effect of the enriched spread on the oxidative status of LDL plasmatic

        -  To evaluate the effect of the enriched spread on the antioxidant defense system

        -  To evaluate the effect of the enriched spread on biomarkers of cardiovascular risk,
           including inflammatory and endothelial damage markers

        -  To evaluate the effect of the enriched spread on the intestinal microbiota.

        -  To evaluate the effect of the enriched spread on the metabolomic changes in plasma.

        -  To analyze the specific genotype of each volunteer
    

Intervention name(s): Enriched spread; Control spread
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): The experimental spread is made with a base made with 90% extra virgin olive oil to which plant sterols are added.; The control spread will be the same base spread made with extra virgin olive oil without the added plant sterols.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Virgin olive oil; Plant Sterols; Hypercholesterolemic children; Olive oil polyphenols