Pilot Study About Extra Virgin Olive Oil "Coratina" in Mild Cognitive Impairment and Alzheimer's Disease Patients

NCT04229186 | Unknown

• 1 other identifier: 5752
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

Alzheimer's Disease is a neurodegenerative disease age related caused by neurofibrillary tangles misfolding and Beta-amyloid protein accumulation. In the last decade several findings showed the role of biophenols present in diary intake such as extra virgin olive oil as potential antagonist of neurodegeneration. Two population studies (The Seven Countries Study and Three-City-Study) and four clinical trials (PREDIMED, PREDIMED - NAVARRA, ACTRIN and ISRCTN) have already suggested that mediterranean diet or other diets supplemented with extra virgin olive oil could improve cerebral performance.

Conditions

Neurodegenerative Diseases

Keywords

Mild Cognitive Impairment; Alzheimer's Disease; Extra Virgin Olive Oil

Outcome Measures

Primary Outcomes (7)

• Evaluate the change of cerebral performance after olive oil supplementation.

  The change of cerebral performance will be documented by neuropsychological assessement with Minimental State Examination (MMSE) (total score)

  Change from baseline MMSE score at 12 months

• Evaluate the change of nutritional parameters after olive oil supplementation

  Weight and height will be combined to report BMI in Kg/m\^2. Nutritional assessment will be measured comparing the variation of BMI of each patient during the follow up.

  Change from baseline BMI at 3 months, from baseline BMI at 6 months, from baseline BMI at 12 months

• Evaluate the change of neurodegenerative biomarkers after olive oil supplementation.

  Neurodegenerative biomarkers will be tested with blood samples and with cerebrospinal fluid analisys (cerebrospinal level of Beta-amiloid, Tau and phospotau, BDNF (pg/mL; blood level of BDNF e NFL (pg/mL))

  Change from baseline neurodegenerative biomarkers at 3 months, from baseline neurodegenerative biomarkerse at 6 months, from baseline neurodegenerative biomarkers at 12 months

• Evaluate the change of neurodegenerative biomarkers after olive oil supplementation.

  Neurodegenerative biomarkers will be tested with blood samples and with cerebrospinal fluid analysis (cerebrospinal level of Beta-amyloid, Tau and phosphotau, BDNF (pg/mL; blood level of BDNF e NFL (pg/mL))

  Change from baseline neurodegenerative biomarkers at 12 months

• Evaluate the change of optic nerve and macula thickness after olive oil supplementation.

  Ocular computerized tomography will be performed and layer of retinal nerve fiber will be measured (micron)

  Change from baseline optic nerve and macula thickness at 12 months

• Evaluate the change of cortical thickness with brain MRI after olive oil supplementation.

  Brain MRI will be performed to assess cortical thickness using Normalized Thickness Index (NTI)

  Change from baseline at 12 months

• Evaluate the change of brain amyloid plaque load (BAPL) after olive oil supplementation.

  Beta amyloid positron emission tomography will be performed measuring a index called BAPL.

  Change from baseline BAPL at 12 months

Study Arms (2)

Patients with assumption of EVOO-C

EXPERIMENTAL

12 patients with Mild Cognitive Impairment or Mild Alzheimer's Disease will receive 10 mg EVOO-C

Dietary Supplement: EVOO-C

Patients with assumption of ROO

EXPERIMENTAL

12 patients with Mild Cognitive Impairment or Mild Alzheimer's Disease will receive 10 mg ROO

Dietary Supplement: ROO

Interventions

EVOO-C DIETARY_SUPPLEMENT

Each patient will consume 10 mg total daily amount EVOO-C

Patients with assumption of EVOO-C

ROO DIETARY_SUPPLEMENT

Each patient will consume 10 mg total daily amount ROO

Patients with assumption of ROO

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• MCI diagnosis in the last month prior the recruitment;
• Clinical Dementia Rating Scale - Global Score (CDR - GS) 0,5 and Mini Mental Examination 24 - 27;

You may not qualify if:

• smoke;
• hypertension;
• diabetes;
• positive history of stroke, epilepsy or cardiac disease;
• BMI \> 30;
• depression or other psychiatric disturbances;
• low compliance to medical interventions;
• positive history of olive oil allergy or intolerance;
• positive history of chronic inflammatory intestinal disease or malabsorption;
• positive history of maculopathy or retinopathy;
• MRI leukoaraiosis II-III grade Fazekas or MRI lacunar infarctions

Sponsors & Collaborators

• University of Bari Aldo Moro: lead
• Med & Food and Schena Foundation: collaborator

Related Publications (5)

• Zhao LN, Long HW, Mu Y, Chew LY. The toxicity of amyloid beta oligomers. Int J Mol Sci. 2012;13(6):7303-7327. doi: 10.3390/ijms13067303. Epub 2012 Jun 13.

  PMID: 22837695 BACKGROUND

• Coppola G, Di Renzo A, Ziccardi L, Martelli F, Fadda A, Manni G, Barboni P, Pierelli F, Sadun AA, Parisi V. Optical Coherence Tomography in Alzheimer's Disease: A Meta-Analysis. PLoS One. 2015 Aug 7;10(8):e0134750. doi: 10.1371/journal.pone.0134750. eCollection 2015.

  PMID: 26252902 BACKGROUND

• Fazekas F, Chawluk JB, Alavi A, Hurtig HI, Zimmerman RA. MR signal abnormalities at 1.5 T in Alzheimer's dementia and normal aging. AJR Am J Roentgenol. 1987 Aug;149(2):351-6. doi: 10.2214/ajr.149.2.351.

  PMID: 3496763 BACKGROUND

• Jack CR Jr, Holtzman DM. Biomarker modeling of Alzheimer's disease. Neuron. 2013 Dec 18;80(6):1347-58. doi: 10.1016/j.neuron.2013.12.003.

  PMID: 24360540 BACKGROUND

• Caminiti SP, Ballarini T, Sala A, Cerami C, Presotto L, Santangelo R, Fallanca F, Vanoli EG, Gianolli L, Iannaccone S, Magnani G, Perani D; BIOMARKAPD Project. FDG-PET and CSF biomarker accuracy in prediction of conversion to different dementias in a large multicentre MCI cohort. Neuroimage Clin. 2018 Jan 28;18:167-177. doi: 10.1016/j.nicl.2018.01.019. eCollection 2018.

  PMID: 29387532 BACKGROUND

MeSH Terms

Conditions

Neurodegenerative Diseases; Cognitive Dysfunction; Alzheimer Disease

Condition Hierarchy (Ancestors)

Nervous System Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Tauopathies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: September 23, 2019
• First Posted: January 18, 2020
• Study Start: January 1, 2020
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2022
• Last Updated: January 18, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share