NCT03779529

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 28, 2018

Completed
4 months until next milestone

First Posted

Study publicly available on registry

December 19, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

December 7, 2020

Status Verified

December 1, 2020

Enrollment Period

2.5 years

First QC Date

August 28, 2018

Last Update Submit

December 4, 2020

Conditions

Chronic Kidney Disease Stage V

Keywords

olive oilhemodialysislipids

Outcome Measures

Primary Outcomes (9)

  • Serum levels of LDL cholesterol

    Blood measurement

    1st month

  • Serum levels of LDL cholesterol

    Blood measurement

    2nd month

  • Serum levels of LDL cholesterol

    Blood measurement

    3rd month

  • Serum levels of HDL cholesterol,

    Blood measurement

    1st month

  • Serum levels of HDL cholesterol,

    Blood measurement

    2nd month

  • Serum levels of HDL cholesterol,

    Blood measurement

    3rd month

  • Serum levels of total cholesterol

    Blood measurement

    1st month

  • Serum levels of total cholesterol

    Blood measurement

    2nd month

  • Serum levels of total cholesterol

    Blood measurement

    3rd month

Secondary Outcomes (6)

  • number of participants with high blood pressure

    1st month

  • number of participants with high blood pressure

    2nd month

  • number of participants with high blood pressure

    3rd month

  • number of participants with myocardial infarction

    Measurement will be done at 1st month

  • number of participants with myocardial infarction

    Measurement will be done at 2nd month

  • +1 more secondary outcomes

Study Arms (2)

Arm label extra-vergin olive oil (EVOO)

ACTIVE COMPARATOR

Participants will ingest two tablespoons of extra-vergin olive oil (EVOO) Coratina during the day: one spoon containing 10g of olive oil (\>5mg of total biophenols/kg of olive oil) at lunch and one at dinner. The total biophenols ingested per day will be \>10mg.

Dietary Supplement: Olive oil

Arm label refined olive oil (ROO)

ACTIVE COMPARATOR

Participants will ingest two tablespoons of refined olive oil during the day: one spoon containing 10 g of refined olive oil at lunch and one at dinner.

Dietary Supplement: Olive oil

Interventions

Olive oilDIETARY_SUPPLEMENT

Intervention includes dosage and amount of biophenols administered daily

Arm label extra-vergin olive oil (EVOO)Arm label refined olive oil (ROO)

Eligibility Criteria

Age40 Years - 80 Years
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The investigators will enroll non-diabetic hypertensive and hyperlipidemic patients undergoing chronic HD
  • Hypertension will be defined as having a systolic blood pressure of \>130 mmHg and a diastolic blood pressure \>80 mmHg or having any antihypertensive agents.
  • Hyperlipidemia will be defined as having LDL cholesterol values more than 100 mg/dl or receiving statins at any dose.
  • Eligible patients may be of any age.

You may not qualify if:

  • Diabetes mellitus type 1 or 2
  • Severe heart failure (NYHA class IV)
  • Patients with low compliance or severe psychiatric illnesses
  • Smoking, intake of antioxidant supplements (eg, carotenoids, vitamin C, vitamin E and glutathione), aspirin, or any other drug with established antioxidant properties, hyperlipidemia, obesity (body mass index \>30 kg/m2), diabetes, celiac or other intestinal disease, life-threatening
  • Survival expectancy \<6 months based on managing physicians assessment
  • Inability to participate in the trial based on managing physicians assessment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione Schena

Valenzano, Bari, 70010, Italy

RECRUITING

Related Publications (3)

  • Palmer SC, Craig JC, Navaneethan SD, Tonelli M, Pellegrini F, Strippoli GF. Benefits and harms of statin therapy for persons with chronic kidney disease: a systematic review and meta-analysis. Ann Intern Med. 2012 Aug 21;157(4):263-75. doi: 10.7326/0003-4819-157-4-201208210-00007.

    PMID: 22910937BACKGROUND

  • Estruch R, Martinez-Gonzalez MA, Corella D, Salas-Salvado J, Ruiz-Gutierrez V, Covas MI, Fiol M, Gomez-Gracia E, Lopez-Sabater MC, Vinyoles E, Aros F, Conde M, Lahoz C, Lapetra J, Saez G, Ros E; PREDIMED Study Investigators. Effects of a Mediterranean-style diet on cardiovascular risk factors: a randomized trial. Ann Intern Med. 2006 Jul 4;145(1):1-11. doi: 10.7326/0003-4819-145-1-200607040-00004.

    PMID: 16818923BACKGROUND

  • Estruch R, Ros E, Salas-Salvado J, Covas MI, Corella D, Aros F, Gomez-Gracia E, Ruiz-Gutierrez V, Fiol M, Lapetra J, Lamuela-Raventos RM, Serra-Majem L, Pinto X, Basora J, Munoz MA, Sorli JV, Martinez JA, Martinez-Gonzalez MA. Retraction and Republication: Primary Prevention of Cardiovascular Disease with a Mediterranean Diet. N Engl J Med 2013;368:1279-90. N Engl J Med. 2018 Jun 21;378(25):2441-2442. doi: 10.1056/NEJMc1806491. Epub 2018 Jun 13. No abstract available.

    PMID: 29897867BACKGROUND

MeSH Terms

Interventions

Olive Oil

Intervention Hierarchy (Ancestors)

Dietary Fats, UnsaturatedDietary FatsFatsLipidsFats, UnsaturatedPlant OilsOilsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Francesco P Schena, MD

    Fondazione Schena

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesco P Schena, MD

CONTACT

3336771291paolo.schena@uniba.it

Giovanni B Pertosa, MD

CONTACT

3476013674giovannibattista.pertosa@uniba.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The olive oils will be administered as oil A or B with content unknown to participants, investigators and outcome assessors
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The general linear model for repeated measurements will be used with multiple paired comparisons in order to assess differences between the groups.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
President and scientif director

Study Record Dates

First Submitted

August 28, 2018

First Posted

December 19, 2018

Study Start

July 1, 2018

Primary Completion

December 31, 2020

Study Completion

December 31, 2021

Last Updated

December 7, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will share

the IPD are shared with other researchers

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
2 years
Access Criteria
publications or reports
More information

Locations

IT(1)