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EVOO Coratina Intervention on Lipids in Non-diabetic Hypertensive Patients Undergoing Hemodialysis (EVOOC-3H)

NCT03779529 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2020-12-07

No results posted yet for this study

Summary

Twenty-four non-diabetic hypertensive and hyperlipidemic patients undergoing periodic chronic hemodialysis will be enrolled for receiving extravirgin olive oil (EVOO) Coratina (12 patients) or refined olive oil (12 patients). Aim of the study is to evaluate the effect of EVOO-C on serum lipid levels. Randomization will be done centrally with appropriate stratification. Sample size is opportunistic because this is a pilot study. Dietary and clinical monitoring will be done by nephrologists, cardiologists and dieticians.

Conditions

  • Chronic Kidney Disease Stage V

Interventions

DIETARY_SUPPLEMENT

Olive oil

Intervention includes dosage and amount of biophenols administered daily

Sponsors & Collaborators

  • University of Bari

    collaborator OTHER

  • Fondazione Schena

    lead OTHER

Principal Investigators

  • Francesco P Schena, MD · Fondazione Schena

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-01
Primary Completion
2020-12-31
Completion
2021-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03779529 on ClinicalTrials.gov