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Effects on Lipid Metabolism of Olive Extracts Rich in Polyphenols

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ClinicalTrials.gov Identifier: NCT03584581
Recruitment Status : Recruiting
First Posted : July 12, 2018
Last Update Posted : July 12, 2018
Sponsor:
Information provided by (Responsible Party):
Ernesto Cortés-Castell, Universidad Miguel Hernandez de Elche

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cholesterol; Metabolic Disorder Metabolic Syndrome Dietary Supplement: Olive polyphenols Dietary Supplement: Control Phase 2

Study Design
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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

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Cholesterols levels [ Time Frame: 1 month ]
    TC, HDL-C, LDL-C and TG.


Secondary Outcome Measures :
  1. BMI (kg/m2) [ Time Frame: 1 month ]
    Weight and height will be combined to report BMI in kg/m^2

  2. Blood pressure [ Time Frame: 1 month ]
    SBP and DBP.

  3. Waist circumference (cm) [ Time Frame: 1 month ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Ernesto Cortés-Castell, PhD +34966658500 ernesto.cortes@umh.es

Locations
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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         
Sponsors and Collaborators
Universidad Miguel Hernandez de Elche
More Information
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Publications:

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Responsible Party: Ernesto Cortés-Castell, Professor, Universidad Miguel Hernandez de Elche
ClinicalTrials.gov Identifier: NCT03584581     History of Changes
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Metabolic Syndrome
Metabolic Diseases
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders