Effects on Lipid Metabolism of Olive Extracts Rich in Polyphenols
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ClinicalTrials.gov Identifier: NCT03584581 |
Recruitment Status : Unknown
Verified July 2018 by Ernesto Cortés-Castell, Universidad Miguel Hernandez de Elche.
Recruitment status was: Recruiting
First Posted : July 12, 2018
Last Update Posted : July 12, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cholesterol; Metabolic Disorder Metabolic Syndrome | Dietary Supplement: Olive polyphenols Dietary Supplement: Control | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Effects on Lipid Metabolism of Olive Extracts Rich in Polyphenols |
Actual Study Start Date : | June 1, 2018 |
Estimated Primary Completion Date : | December 31, 2018 |
Estimated Study Completion Date : | December 31, 2018 |

Arm | Intervention/treatment |
---|---|
Experimental: Olive polyphenols |
Dietary Supplement: Olive polyphenols
The amount of polyphenols to be supplied is within the ranges of absolute biosecurity food described by different authors and used in different studies. |
Placebo Comparator: Control |
Dietary Supplement: Control
Placebo |
- Cholesterols levels [ Time Frame: 1 month ]TC, HDL-C, LDL-C and TG.
- BMI (kg/m2) [ Time Frame: 1 month ]Weight and height will be combined to report BMI in kg/m^2
- Blood pressure [ Time Frame: 1 month ]SBP and DBP.
- Waist circumference (cm) [ Time Frame: 1 month ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients with dyslipidemia without the need for pharmacological treatment, but with annual follow-up of their dyslipidemia and with baseline LDL-cholesterol values.
- Patients to whom the annual analysis will be carried out for control of the lipid profile and who agree to postpone it during the month of the health education study.
- Patients who undergo hygienic-dietetic intervention and exercise.
- Patients willing to ingest the nutritional supplement of polyphenols that will be supplied to them.
- Signed the informed consent.
Exclusion Criteria:
- <18 years old.
- High cardiovascular risk.
- With pharmacological treatment.
- With some previous chronic disease.
- With some allergy to the compounds of the product and placebo according to the technical specifications.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03584581
Contact: Ernesto Cortés-Castell, PhD | +34966658500 | ernesto.cortes@umh.es |
Spain | |
General University Hospital of Elda | Recruiting |
Elda, Alicante, Spain, 03690 | |
Contact: Vicente F Gil-Guillén, MD, PhD +34966975017 vte.gil@gmail.com | |
Principal Investigator: Ernesto Cortés-Castell, PhD | |
Sub-Investigator: Antonio Palazón-Bru, PhD | |
Sub-Investigator: María M Rizo-Baeza, PhD | |
Sub-Investigator: Vicente F Gil-Guillén, MD, PhD | |
Sub-Investigator: Luís Torró-Montell, MPharm | |
Sub-Investigator: Enrique Hermida-Campa, MD, PhD |
Responsible Party: | Ernesto Cortés-Castell, Professor, Universidad Miguel Hernandez de Elche |
ClinicalTrials.gov Identifier: | NCT03584581 |
Other Study ID Numbers: |
PI2016/13 nº 77 |
First Posted: | July 12, 2018 Key Record Dates |
Last Update Posted: | July 12, 2018 |
Last Verified: | July 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | The data will not be publicly available. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Metabolic Syndrome Metabolic Diseases Insulin Resistance Hyperinsulinism Glucose Metabolism Disorders |