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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

Tracking Information
First Submitted Date  ICMJE June 27, 2018
First Posted Date  ICMJE July 12, 2018
Last Update Posted Date July 12, 2018
Actual Study Start Date  ICMJE June 1, 2018
Estimated Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 11, 2018)
Cholesterols levels [ Time Frame: 1 month ]
TC, HDL-C, LDL-C and TG.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 11, 2018)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects on Lipid Metabolism of Olive Extracts Rich in Polyphenols
Official Title  ICMJE Effects on Lipid Metabolism of Olive Extracts Rich in Polyphenols
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Cholesterol; Metabolic Disorder
  • Metabolic Syndrome
Intervention  ICMJE
  • 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.
  • Dietary Supplement: Control
    Placebo
Study Arms  ICMJE
  • Experimental: Olive polyphenols
    Intervention: Dietary Supplement: Olive polyphenols
  • Placebo Comparator: Control
    Intervention: Dietary Supplement: Control
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 11, 2018)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2018
Estimated Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ernesto Cortés-Castell, PhD +34966658500 ernesto.cortes@umh.es
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03584581
Other Study ID Numbers  ICMJE PI2016/13 nº 77
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: The data will not be publicly available.
Responsible Party Ernesto Cortés-Castell, Universidad Miguel Hernandez de Elche
Study Sponsor  ICMJE Universidad Miguel Hernandez de Elche
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Universidad Miguel Hernandez de Elche
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP