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Completed

NCT Number: NCT05460208

Hypocholesterolemic Effect of a Phytosterol-enriched Spreadable Cream Prepared With Virgin Olive Oil

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.

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Key information

Conditions

Hypercholesterolemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario Reina Sofia de Córdoba, Córdoba, Spain

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age between 6 and 18 years
  • Familial hypercholesterolemia
  • Acceptance to participate by signing the informed consent

Exclusion criteria

  • Children under 6 years of age
  • Absence of hypercholesterolemia
  • Children who receive some type of medication to control hypercholesterolemia, blood pressure, levels of glucose or dyslipidemia or any probiotic, which have invalid data for the variables of the present study
  • Not to sign the informed consent.

Treatment and study plan

Enriched spread

Dietary Supplement

The experimental spread is made with a base made with 90% extra virgin olive oil to which plant sterols are added.

Control spread

Dietary Supplement

The control spread will be the same base spread made with extra virgin olive oil without the added plant sterols.

Primary outcomes

  1. Hypercholesterolemia

    Time frame: Month 0; Month 2; Month 3; Month 5

    Assessing changes of plasma lipids levels from the baseline to the end of each treatment. The serum concentrations of total cholesterol (mg/dL), triglycerides (TG, (mg/dL)), high-density lipoprotein cholesterol (HDLc, (mg/dL)), and low-density lipoprotein cholesterol (LDLc, (mg/dL)), apolipoprotein A1 (Apo-A1, (mg/dL)) and apolipoprotein B (Apo-B, (mg/dL)) will be analyzed by spectrophotometry.

Secondary outcomes

  1. Body composition

    Time frame: Month 0; Month 2; Month 3; Month 5

    Assessing changes of body composition from the baseline to the end of each treatment. To obtain data on body composition, fat mass (kg), lean mass (kg) and total body water (kg) will be measured via bioimpedance technology using TANITA MC-780MA (Tokyo, Japan).

  2. Body composition percentages

    Time frame: Month 0; Month 2; Month 3; Month 5

    Assessing changes of body composition percentages from the baseline to the end of each treatment. To obtain data on body composition, fat mass (percent), lean mass (percent) and total body water (percent) will be measured via bioimpedance technology using TANITA MC-780MA (Tokyo, Japan).

  3. Systolic blood pressure

    Time frame: Month 0; Month 2; Month 3; Month 5

    Assessing changes of Systolic Blood Pressure from the baseline to the end of each treatment.

  4. Diastolic blood pressure

    Time frame: Month 0; Month 2; Month 3; Month 5

    Assessing changes of Diastolic Blood Pressure from the baseline to the end of each treatment.

  5. Oxidation biomarkers

    Time frame: Month 0; Month 2; Month 3; Month 5

    Assessing changes of oxidized LDL from the baseline to the end of each treatment, by using an ELISA kit

  6. Enzymatic antioxidant status

    Time frame: Month 0; Month 2; Month 3; Month 5

    Assessing changes on erythrocyte antioxidant enzymes (catalase, superoxide dismutase, glutathione peroxidase and glutathione reductase) from the baseline to the end of each treatment, by using spectrophotometric kits.

  7. Non-enzymatic antioxidant status

    Time frame: Month 0; Month 2; Month 3; Month 5

    Assessing changes on plasma liposoluble antioxidants (retinol, beta-carotene and Q-coenzyme) from the baseline to the end of each treatment, by HPLC.

  8. Endothelial function status

    Time frame: Month 0; Month 2; Month 3; Month 5

    Assessing changes on plasma endothelin-1 from the baseline to the end of each treatment, by using an ELISA kit.

  9. Endothelial damage

    Time frame: Month 0; Month 2; Month 3; Month 5

    Assessing changes on plasma VCAM , ICAM-1, E-selectin and mielopeoxidasa from the baseline to the end of each treatment, by Luminex xMAP technology.

  10. Fecal microbiome

    Time frame: Month 0; Month 2; Month 3; Month 5

    Assessing changes of fecal microbiome profile from the baseline to the end of each treatment. Stool DNA will be isolated with the QIAamp DNA stool mimi kit. Amplification of variable region V3-V1 of 16S gen will be sequenced using the Illunina Next Generation Sequencing MiSeg.

  11. Plasma metabolomic analysis

    Time frame: Month 0; Month 2; Month 3; Month 5

    A liquid chromatography platform coupled to a spectrophotometer will be used mass (LC/MS) to determine plasma metabolic profiles by targeted analyses from the baseline to the end of each treatment.

  12. Urine metabolomic analysis

    Time frame: Month 0; Month 2; Month 3; Month 5

    A liquid chromatography platform coupled to a spectrophotometer will be used mass (LC/MS) to determine urine metabolic profiles by targeted analyses from the baseline to the end of each treatment.

Sponsors and collaborators

Lead sponsor

Universidad de Granada

Other

Collaborators

  • Hospital Universitario Reina Sofia de Cordoba
  • Maimónides Biomedical Research Institute of Córdoba

Registry information

Official study title

Hypocholesterolemic and Cardioprotective Clinical Evaluation of a Spreadable Cream Prepared With Virgin Olive Oil Enriched in Phytosterols and Bioactive Compounds From Olives in Children and Adolescents

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jul 15, 2022
Registry last updated
Jul 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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