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Auburn University Research on Olive Oil for Alzheimer's Disease (AU-ROOAD) ((AU-ROOAD))

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03824197
Recruitment Status : Active, not recruiting
First Posted : January 31, 2019
Last Update Posted : July 8, 2020
Sponsor:
Information provided by (Responsible Party):
Amal Kaddoumi, Auburn University

Tracking Information
First Submitted Date  ICMJE January 28, 2019
First Posted Date  ICMJE January 31, 2019
Last Update Posted Date July 8, 2020
Actual Study Start Date  ICMJE May 7, 2019
Estimated Primary Completion Date December 8, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 29, 2019)
  • Effect of olive oil on the BBB intactness [ Time Frame: 6 months ]
    Will be evaluated by DCE-MRI
  • Effect of olive oil on the brain activity [ Time Frame: 6 months ]
    Will be evaluated by fMRI
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 29, 2019)
Cognitive function [ Time Frame: 6 months ]
A battery of cognitive tasks to assess memory
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 Auburn University Research on Olive Oil for Alzheimer's Disease (AU-ROOAD)
Official Title  ICMJE Extra-virgin Olive Oil Prevents Mild Cognitive Impairment Conversion to Alzheimer's Disease
Brief Summary

Until now there is no medical treatment and/or intervention that can slow, stop or reverse the underlying neurodegenerative of Alzheimer's disease (AD). The goal of this study is to demonstrate "Oleocanthal rich-extra-virgin olive oil (EVOO) consumption stops or delay mild cognitive impairment conversion to AD by restoring the blood-brain barrier (BBB) function in humans".

Specific Aims:

  1. Evaluate effect of EVOO on the brain function by functional MRI (fMRI) imaging, and BBB function by dynamic contrast-enhanced MRI (DCE-MRI).
  2. Evaluate effect of EVOO on cognitive function and on selected biomarkers
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Condition  ICMJE
  • Alzheimer Disease
  • Cerebral Amyloid Angiopathy
Intervention  ICMJE
  • Other: EVOO
    Extra-virgin olive oil that is rich with oleocanthal and other phenols.
    Other Name: OC-rich EVOO
  • Other: OO
    Olive oil low in oleocanthal and other phenols.
    Other Name: Olive oil
Study Arms  ICMJE
  • EVOO-phenol high
    Extra-virgin olive oil rich with oleocanthal and other phenolic compounds that will be added to daily diet
    Intervention: Other: EVOO
  • OO-phenol low
    Olive oil with low phenolic content that will be added to daily diet
    Intervention: Other: OO
Publications * Not Provided

*   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 Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: January 29, 2019)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2020
Estimated Primary Completion Date December 8, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Men and women, experiencing mild cognitive impairment with:

  1. Mini-Mental State Exam (MMSE) scores between 18-30 (based on education level
  2. memory complaint, have objective memory loss measured by education adjusted scores on Wechsler Memory Scale Logical Memory VI
  3. Clinical Dementia Rating (CDR) score 0.5.

Exclusion Criteria:

  1. Subjects with contradictions for MRI include: the presence of metal or electronic devices such as metallic joint prostheses, artificial heart valves, an implantable heart defibrillator, a pacemaker, metal clips, cochlear implants, a bullet, shrapnel or any other type of metal fragment; breathing problems or disorders, claustrophobia, inner ear disorders, vertigo or dizziness, tattoos or permanent makeup that contains metal, and body piercing jewelry that cannot be removed.
  2. Subjects will be excluded if they are smokers
  3. Subjects who have have clinically important medical or neuropsychiatric comorbidity.
  4. Subjects who have renal problems or are allergic to the MRI contrast agent.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03824197
Other Study ID Numbers  ICMJE 18-446 MR 1901
Has Data Monitoring Committee Not Provided
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 Not Provided
Responsible Party Amal Kaddoumi, Auburn University
Study Sponsor  ICMJE Auburn University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Amal Kaddoumi, PhD Auburn University
PRS Account Auburn University
Verification Date July 2020

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