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Effects on Lipid Metabolism of Olive Extracts Rich in Polyphenols

M

Miguel Hernández University of Elche

Status and phase

Unknown
Phase 2

Conditions

Cholesterol; Metabolic Disorder
Metabolic Syndrome

Treatments

Dietary Supplement: Olive polyphenols
Dietary Supplement: Control

Study type

Interventional

Funder types

Other

Identifiers

NCT03584581
PI2016/13 nº 77

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

60 participants in 2 patient groups, including a placebo group

Olive polyphenols
Experimental group
Treatment:
Dietary Supplement: Olive polyphenols
Control
Placebo Comparator group
Treatment:
Dietary Supplement: Control

Trial contacts and locations

1

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Central trial contact

Ernesto Cortés-Castell, PhD

Data sourced from clinicaltrials.gov

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