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

Hypercholesterolemia Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05460208
• Other study ID #: MEDKIDS-Chol
• Secondary ID: IDI-20190983
• Status: Completed
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: July 2022
• Source: Universidad de Granada
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 31, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Dietary Supplement:
• Enriched spread
The experimental spread is made with a base made with 90% extra virgin olive oil to which plant sterols are added.
• Control spread
The control spread will be the same base spread made with extra virgin olive oil without the added plant sterols.

Locations

Country	Name	City	State
Spain	Hospital Universitario Reina Sofia de Córdoba	Córdoba
Spain	Universidad de Granada	Granada

Sponsors (3)

Lead Sponsor	Collaborator
Universidad de Granada	Hospital Universitario Reina Sofia de Cordoba, Maimónides Biomedical Research Institute of Córdoba

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hypercholesterolemia	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.	Month 0; Month 2; Month 3; Month 5
Secondary	Body composition	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).	Month 0; Month 2; Month 3; Month 5
Secondary	Body composition percentages	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).	Month 0; Month 2; Month 3; Month 5
Secondary	Systolic blood pressure	Assessing changes of Systolic Blood Pressure from the baseline to the end of each treatment.	Month 0; Month 2; Month 3; Month 5
Secondary	Diastolic blood pressure	Assessing changes of Diastolic Blood Pressure from the baseline to the end of each treatment.	Month 0; Month 2; Month 3; Month 5
Secondary	Oxidation biomarkers	Assessing changes of oxidized LDL from the baseline to the end of each treatment, by using an ELISA kit	Month 0; Month 2; Month 3; Month 5
Secondary	Enzymatic antioxidant status	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.	Month 0; Month 2; Month 3; Month 5
Secondary	Non-enzymatic antioxidant status	Assessing changes on plasma liposoluble antioxidants (retinol, beta-carotene and Q-coenzyme) from the baseline to the end of each treatment, by HPLC.	Month 0; Month 2; Month 3; Month 5
Secondary	Endothelial function status	Assessing changes on plasma endothelin-1 from the baseline to the end of each treatment, by using an ELISA kit.	Month 0; Month 2; Month 3; Month 5
Secondary	Endothelial damage	Assessing changes on plasma VCAM , ICAM-1, E-selectin and mielopeoxidasa from the baseline to the end of each treatment, by Luminex xMAP technology.	Month 0; Month 2; Month 3; Month 5
Secondary	Fecal microbiome	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.	Month 0; Month 2; Month 3; Month 5
Secondary	Plasma metabolomic analysis	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.	Month 0; Month 2; Month 3; Month 5
Secondary	Urine metabolomic analysis	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.	Month 0; Month 2; Month 3; Month 5