Management of Mild Cognitive Impairment Patients With Extra Virgin Olive Oil - MICOIL

NCT03362996 | Unknown Phase 2

• 1 other identifier: 25/201614
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

There is accumulating evidence suggesting that olive oil may have a positive impact on conditions involving cognitive deficits, such as MCI and AD. More specifically, these beneficial effects are mostly attributed to some phenolic compounds in olive oil, such as oleocanthal, oleuropein and ligstroside. Oleocanthal is deeper studied than the rest of olive oil phenol components and it shows promising results in neuroprotection against AD through various suggested mechanisms, such as the enhancement of amyloid-beta clearance in the brain and the inhibition of neurofibrillary tangles formation. For this reason, it would be interesting to study the effects of freshly-pressed extra virgin olive oil, as it is known that it contains oleocanthal in higher concentrations than the normal extra virgin olive oil. The aim of the study is to evaluate the beneficial effect of extra virgin olive oil in comparison to freshly-pressed extra virgin olive oil on patients diagnosed with mild cognitive impairment (MCI). Study Type: Interventional Study Design: Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention

Conditions

Mild Cognitive Impairment

Keywords

extra virgin olive oil; mild cognitive impairment; randomized double blind clinical trial

Outcome Measures

Primary Outcomes (15)

• Neuropsychological Assessment- Measurements to Assess General Cognitive Function

  Changes in Mini-Mental State Examination (MMSE) score

  baseline, 12 and 24 months

• FUCAS-Measurements to Assess Daily Functionality

  Changes in Functional cognitive assessment scale (FUCAS) score

  baseline, 12 and 24 months

• Letter & Category Fluency Test- Measurement to Assess Verbal Fluency and Learning

  Changes in the Letter \& Category Fluency Test

  baseline, 12 and 24 months

• CDR- Measurements to Assess General Cognitive Function

  Changes in Global Clinical Dementia Rating (CDR) score (sum of boxes)

  baseline, 12 and 24 months

• MoCA- Measurements to Assess General Cognitive Function

  Changes in Montreal Cognitive Assessment (MoCA)

  baseline, 12 and 24 months

• CANTAB- Measurements to Assess General Cognitive Function

  Changes in Cambridge Neuropsychological Test Automated Battery (CANTAB)

  baseline, 12 and 24 months

• Clock Drawing test- Measurements to Assess General Cognitive Function

  Changes in the Clock Drawing test

  baseline, 12 and 24 months

• Logical Memory test- Measurements to Assess General Cognitive Function

  Changes in the Logical Memory test

  baseline, 12 and 24 months

• Digit Span Forward & Backward test- Measurements to Assess General Cognitive Function

  Changes in the Digit Span Forward \& Backward test

  baseline, 12 and 24 months

• WAIS-R Digit Symbol- Measurements to Assess General Cognitive Function

  Changes in the WAIS-R Digit Symbol Substitution Test

  baseline, 12 and 24 months

• TMT part A and B- Measurements to Assess General Cognitive Function

  Changes in the Trail Making Test

  baseline, 12 and 24 months

• ADASCog-Measurements to Assess Daily Functionality

  Changes in Alzheimer's Disease Assessment Scale-Cognitive (ADASCog)

  baseline, 12 and 24 months

• Functional Rating Scale for Dementia-Measurements to Assess Daily Functionality

  Changes in Functional Rating Scale for Dementia (FRSSD)

  baseline, 12 and 24 months

• Auditory Verbal Learning Test- Measurement to Assess Verbal Fluency and Learning

  Changes in the Auditory Verbal Learning Test

  baseline, 12 and 24 months

• Boston Naming Test- Measurement to Assess Verbal Fluency and Learning

  Changes in the Boston Naming Test

  baseline, 12 and 24 months

Secondary Outcomes (5)

• NeuroImaging

  baseline and 24 months

• CSF - beta amyloid

  baseline and 24 months

• CSF TAU-protein

  baseline and 24 months

• Neurophysiology and ERPs

  baseline, 12 and 24 months

• Electroencephalography recording

  baseline, 12 and 24 months

Other Outcomes (2)

• Weight in Kilograms

  baseline, 12 and 24 months

• Height in Meters

  baseline, 12 month and 24 month

Study Arms (3)

Experimental Group

EXPERIMENTAL

50 patients Freshly-Pressed Extra Virgin Olive Oil Aluminum bottle with 500 ml of freshly-pressed extra virgin olive oil 1 bottle per 10 days. Dietary Supplement: Freshly-Pressed Extra Virgin Olive Oil dietary intake of the content of 50 mL (3 tablespoons from the bottle containing the product)

Dietary Supplement: Freshly-Pressed Extra Virgin Olive Oil

Control group 1

PLACEBO COMPARATOR

50 patients Extra Virgin Olive Oil Aluminum bottle with 500 ml of freshly-pressed extra virgin olive oil 1 bottle per 10 days. Extra Virgin Olive Oil dietary intake of the content of 50 mL (3 tablespoons from the bottle containing the product)

Combination Product: extra virgin olive oil

Control Group 2

OTHER

50 patients that will have the same dietary habits and a Mediterranean dietary protocol

Other: mediterranean diet

Interventions

Freshly-Pressed Extra Virgin Olive Oil DIETARY_SUPPLEMENT

Dietary Supplement: Freshly-pressed extra virgin olive oil Freshly-Pressed Extra Virgin Olive Oil Aluminum bottle with 500 ml of freshly-pressed extra virgin olive oil 1 bottle per 10 days

Experimental Group

extra virgin olive oil COMBINATION_PRODUCT

Extra Virgin Olive Oil Aluminum bottle with 500 ml of freshly-pressed extra virgin olive oil 1 bottle per 10 days

Control group 1

mediterranean diet OTHER

50 patients that will have the same dietary habits and a Mediterranean dietary protocol

Control Group 2

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Memory Complaints
• Abnormal memory function documented by scoring 1 SD below the age-adjusted mean on the Logical Memory II subscale, (Delayed Paragraph Recall) from the Wechsler Memory Scale-R.
• MMSE 24-30
• CDR(sum of boxes) \>= 0,5
• Diagnosis: Mild Cognitive Impairment (amnestic plus multi-domain)
• Geriatric Depression Scale (GDS) \<6
• Hachinski Modified Ischemic scale \<= 4
• Stability of Permitted Medications for 4 weeks
• Years of education: \>= 5
• Proficient language fluency
• Have a study partner with 10+ hr/wk contact (can be in person and telephone), accompanies to visits
• Compliance

You may not qualify if:

• Visual and auditory acuity inadequate for neuropsychological testing
• Enrollment in other trials or studies not compatible with MICOIL
• History of significant neurological or psychiatric illnesses or presence of other diseases precluding enrollment.
• Use of forbidden medications (listed below)
• Ferromagnetic implants and devices (including implants or devices held in place by sutures, granulation or ingrowth of tissue, fixation devices, or by other means) not eligible for MRI scanning. Brain malformation or other conditions that may complicate lumbar puncture
• Medications across the study
• Excluded Medication:
• Antidepressants with anti-cholinergic properties.
• Regular use of narcotic analgesics (\>2 doses per week) within 4 weeks of screening.
• Use of neuroleptics with anti-cholinergic properties (e.g., chlorpromazine, thioridazine) within 4 weeks of screening.
• Chronic use of other medications with significant central nervous system anticholinergic activity within 4 weeks of screening (e.g., diphenhydramine).
• Use of Anti-Parkinsonian medications (including Sinemet, amantadine, bromocriptine, pergolide, selegeline) within 4 weeks of screening.
• Participation in any other investigational drug study within 4 weeks of screening (individuals may not participate in any drug study while participating in this protocol).

Sponsors & Collaborators

• Greek Alzheimer's Association and Related Disorders: lead

Study Sites (1)

Greek Association of Alzheimer's Disease and Related Disordeers

Thessaloniki, 54248, Greece

RECRUITING

Related Publications (3)

• Tsolaki M, Karathanasi E, Lazarou I, Dovas K, Verykouki E, Karacostas A, Georgiadis K, Tsolaki A, Adam K, Kompatsiaris I, Sinakos Z. Efficacy and Safety of Crocus sativus L. in Patients with Mild Cognitive Impairment: One Year Single-Blind Randomized, with Parallel Groups, Clinical Trial. J Alzheimers Dis. 2016 Jul 27;54(1):129-33. doi: 10.3233/JAD-160304.

  PMID: 27472878 BACKGROUND

• Tzekaki EE, Tsolaki M, Geromichalos GD, Pantazaki AlphaA. Extra Virgin Olive Oil consumption from Mild Cognitive Impairment patients attenuates oxidative and nitrative stress reflecting on the reduction of the PARP levels and DNA damage. Exp Gerontol. 2021 Dec;156:111621. doi: 10.1016/j.exger.2021.111621. Epub 2021 Nov 5.

  PMID: 34748951 DERIVED

• Tzekaki EE, Tsolaki M, Pantazaki AlphaA, Geromichalos G, Lazarou E, Kozori M, Sinakos Z. The pleiotropic beneficial intervention of olive oil intake on the Alzheimer's disease onset via fibrinolytic system. Exp Gerontol. 2021 Jul 15;150:111344. doi: 10.1016/j.exger.2021.111344. Epub 2021 Apr 6.

  PMID: 33836262 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Diet, Mediterranean

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Magda Tsolaki, Professor

  Greek Alzheimer's Association and Related Disorders

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Magda Tsolaki, Professor

CONTACT

0030 2310 2411 56; tsolakim1@gmail.com

Eutuchia Lazarou, MSc

CONTACT

0030 6934664446; lazfelicia@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2017
• First Posted: December 5, 2017
• Study Start: November 9, 2016
• Primary Completion: February 15, 2018
• Study Completion: May 15, 2019
• Last Updated: January 8, 2018

Record last verified: 2018-01

Locations

GR (1)