HypercholesterolemiaNCT05460208
Hypocholesterolemic Effect of a Phytosterol-enriched Spreadable Cream Prepared With Virgin Olive Oil
A study testing Enriched spread in people with Hypercholesterolemia, run by Universidad de Granada at 2 sites in Spain.
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. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- Enriched spread
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 2 sitesSpain
- Study dates
- 1 Jan 2021to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age between 6 and 18 years
- Familial hypercholesterolemia
- Acceptance to participate by signing the informed consent
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
Spain2 sites
Hospital Universitario Reina Sofia de Córdoba
Córdoba, 14004
Universidad de Granada
Granada, 18071
About this study
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
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.
Read the 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
- Conditions
- Hypercholesterolemia
- Being tested
- Enriched spread, Control spread
- Keywords
- Virgin olive oil, Plant Sterols, Hypercholesterolemic children, Olive oil polyphenols
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enriched spreadDietary supplement
The experimental spread is made with a base made with 90% extra virgin olive oil to which plant sterols are added.
Control spreadDietary supplement
The control spread will be the same base spread made with extra virgin olive oil without the added plant sterols.
| Study group | Role | What they receive |
|---|---|---|
| Enriched spread | Experimental | 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) Receives: Dietary Supplement: Enriched spread |
| Control spread | Placebo comparator | 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) Receives: Dietary Supplement: Control spread |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Month 0; Month 2; Month 3; Month 5
Secondary outcomes (12)
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).
Measured: Month 0; Month 2; Month 3; Month 5
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).
Measured: Month 0; Month 2; Month 3; Month 5
Systolic blood pressure
Assessing changes of Systolic Blood Pressure from the baseline to the end of each treatment.
Measured: Month 0; Month 2; Month 3; Month 5
Diastolic blood pressure
Assessing changes of Diastolic Blood Pressure from the baseline to the end of each treatment.
Measured: Month 0; Month 2; Month 3; Month 5
Oxidation biomarkers
Assessing changes of oxidized LDL from the baseline to the end of each treatment, by using an ELISA kit
Measured: Month 0; Month 2; Month 3; Month 5
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.
Measured: Month 0; Month 2; Month 3; Month 5
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.
Measured: Month 0; Month 2; Month 3; Month 5
Endothelial function status
Assessing changes on plasma endothelin-1 from the baseline to the end of each treatment, by using an ELISA kit.
Measured: Month 0; Month 2; Month 3; Month 5
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.
Measured: Month 0; Month 2; Month 3; Month 5
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.
Measured: Month 0; Month 2; Month 3; Month 5
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.
Measured: Month 0; Month 2; Month 3; Month 5
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.
Measured: Month 0; Month 2; Month 3; Month 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2022
- Study start1 Jan 2021
- Primary completion30 Jun 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario Reina Sofia de Cordoba, Maimónides Biomedical Research Institute of Córdoba
- Responsible party
- Principal investigator, María Dolores Mesa García, Universidad de Granada
- Investigators
- MARÍA DOLORES MESA GARCÍA, Principal investigator, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05460208
- Sponsor's protocol ID
- MEDKIDS-Chol
- Other IDs
- IDI-20190983
- Status last verified
- Jul 2022
- First submitted
- 7 Mar 2022
- Last updated
- 19 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Garcia-Perez P, Vazquez-Aguilar A, Sanchez-Rodriguez E, Jurado-Castro JM, Pastor-Villaescusa B, Gil-Campos M, Rangel-Huerta OD, Gil A, Aguilera CM, Mesa MD, Rocchetti G, Lucini L. Chemometrics-guided plasma lipidomics insights underlying the decrease of plasma total cholesterol and LDLc in children with hypercholesterolemia following habitual intake of an EVOO-based phytosterols-enriched spreadable cream. Metabolomics. 2025 Nov 15;21(6):169. doi: 10.1007/s11306-025-02368-3.
PubMed 41241688
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05460208
- Acronym / sponsor ID
- MEDKIDS-Chol
- Conditions
- Hypercholesterolemia
- Keywords
- Virgin olive oil, Plant Sterols, Hypercholesterolemic children, Olive oil polyphenols
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Collaborators
- Hospital Universitario Reina Sofia de Cordoba, Maimónides Biomedical Research Institute of Córdoba
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 15 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enriched spread | Experimental | Dietary Supplement: Enriched spreadChildren 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) |
| Control spread | Placebo comparator | Dietary Supplement: Control spreadChildren 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) |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Age between 6 and 18 years
- Familial hypercholesterolemia
- Acceptance to participate by signing the informed consent
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enriched spreadThe experimental spread is made with a base made with 90% extra virgin olive oil to which plant sterols are added. | Dietary supplement | Enriched spread |
| Control spreadThe control spread will be the same base spread made with extra virgin olive oil without the added plant sterols. | Dietary supplement | Control spread |
Primary outcome
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.
12 secondary outcomes
Body composition
Time frame: Month 0; Month 2; Month 3; Month 5
Body composition percentages
Time frame: Month 0; Month 2; Month 3; Month 5
Systolic blood pressure
Time frame: Month 0; Month 2; Month 3; Month 5
Diastolic blood pressure
Time frame: Month 0; Month 2; Month 3; Month 5
Oxidation biomarkers
Time frame: Month 0; Month 2; Month 3; Month 5
Enzymatic antioxidant status
Time frame: Month 0; Month 2; Month 3; Month 5
Non-enzymatic antioxidant status
Time frame: Month 0; Month 2; Month 3; Month 5
Endothelial function status
Time frame: Month 0; Month 2; Month 3; Month 5
Endothelial damage
Time frame: Month 0; Month 2; Month 3; Month 5
Fecal microbiome
Time frame: Month 0; Month 2; Month 3; Month 5
Plasma metabolomic analysis
Time frame: Month 0; Month 2; Month 3; Month 5
Urine metabolomic analysis
Time frame: Month 0; Month 2; Month 3; Month 5
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2022.
- Derived from this study: PubMed 41241688Garcia-Perez P, Vazquez-Aguilar A, Sanchez-Rodriguez E, Jurado-Castro JM, Pastor-Villaescusa B, Gil-Campos M, Rangel-Huerta OD, Gil A, Aguilera CM, Mesa MD, Rocchetti G, Lucini L. Chemometrics-guided plasma lipidomics insights underlying the decrease of plasma total cholesterol and LDLc in children with hypercholesterolemia following habitual intake of an EVOO-based phytosterols-enriched spreadable cream. Metabolomics. 2025 Nov 15;21(6):169. doi: 10.1007/s11306-025-02368-3.
- Individual participant dataSharing planned: No
Related trials for Hypercholesterolemia
Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
Active, not recruitingObservational study
Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
Familial Hypercholesterolaemia
Not yet recruiting
Penn Family Screening for Familial Hypercholesterolemia (NHLBI R33) Trial 3
Familial Hypercholesterolemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MARÍA DOLORES MESA GARCÍA principal investigator
Universidad de Granada
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enriched spread in people with Hypercholesterolemia, run by Universidad de Granada at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hypercholesterolemia (time frame: Month 0; Month 2; Month 3; Month 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05460208, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2022.