Effects on Lipid Metabolism of Olive Extracts Rich in Polyphenols

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03584581

Enrollment

Registered

2018-07-12

Start date

2018-06-01

Completion date

2018-12-31

Last updated

2018-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cholesterol; Metabolic Disorder, Metabolic Syndrome

Brief summary

This study is designed to determine whether a standardized intervention in the health center and based on hygienic dietary measures and physical exercise, supplemented with a polyphenol extract in patients, achieves a greater benefit in the reduction of LDL cholesterol in dyslipidemias in the short term.

Interventions

DIETARY_SUPPLEMENTOlive 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.

DIETARY_SUPPLEMENTControl

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Cholesterols levels	1 month	TC, HDL-C, LDL-C and TG.

Secondary

Measure	Time frame	Description
BMI (kg/m2)	1 month	Weight and height will be combined to report BMI in kg/m\^2
Blood pressure	1 month	SBP and DBP.
Waist circumference (cm)	1 month	—

Countries

Spain

Contacts

Primary ContactErnesto Cortés-Castell, PhD

ernesto.cortes@umh.es+34966658500

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026