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

University of Granada (UGR)

Status: Completed

Conditions: Hypercholesterolemia

Treatments: Dietary Supplement: Enriched spread; Dietary Supplement: Control spread

Study type: Interventional

Funder types: Other

Identifiers

NCT05460208

IDI-20190983 (Other Grant/Funding Number)

MEDKIDS-Chol

Details and patient eligibility

About

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.

Full 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

Enrollment: 50 patients

Sex: All

Ages: 6 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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50 participants in 2 patient groups, including a placebo group

Enriched spread

Experimental group

Description:

Children between 20-40 kg will receive a dose of 15 g of the spread (1.2 g/d of plant sterols: 0.06-0.03 g/kg of weight/d) and those with a weight between 40-60 kg will receive two doses of 15 g of the spread (2.4 g/d of plant sterols: 0.06-0.04 g/kg of weight/d)

Treatment:

Dietary Supplement: Enriched spread

Control spread

Placebo Comparator group

Description:

Children between 20-40 kg will receive a dose of 15 g of the spread (1.2 g/d of plant sterols: 0.06-0.03 g/kg of weight/d) and those with a weight between 40-60 kg will receive two doses of 15 g of the spread (2.4 g/d of plant sterols: 0.06-0.04 g/kg of weight/d)

Treatment:

Dietary Supplement: Control spread