The Effect of Combination of Mediterranean Diet and Oleocanthal in Patients with Mild Cognitive Impairment

NCT06705738 | Active Not Recruiting

• 1 other identifier: AUTh
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

Brief Summary

BACKGROUND: Mild cognitive impairment (MCI) constitutes a form of preclinical dementia and characterizes a cognitive decline that exceeds what is expected for one's age and education status, but at the same time does not fulfill the criteria for dementia. MCI is considered a prodromal stage of Alzheimer's disease (AD) and the progression to this neurodegenerative disease, renders the patients heavily dependent on their relatives and the society, which creates a huge psychological and financial burden, since no effective treatment exists for MCI and AD to this day. Mediterranean diet (MeDi) displays beneficial effects on the cognitive function of both healthy individuals and cognitive impaired patients. High Phenolic Early Harvest Extra Virgin Olive Oil (HP-EH-EVOO) is a natural product that contains high concentrations of the substance Oleocanthal (OLC), while at the same time it has been shown to exert beneficial properties on the cognitive function of cognitive impaired individuals, as well as on the slowing down of the decline of cognitive function. AIM: The main hypothesis that will be evaluated is whether the combined approach of the MeDi pattern and the concurrent intervention with the administration in a capsule form of the supplement containing olive oil polyphenols with the main substance being Oleocanthal (SUPOL), could constitute a considerable strategy of management of MCI patients. Study Type: Investigational Study Design, Allocantion: Randomized Intervention Model, Parallel Assignment Masking: Single Blind (Outcome Assessor - Investigator) on Diet, Double Blind (Subject, Outcome Assessor - Investigator) on Supplement, Primary Purpose: Prevention.

Conditions

Mild Cognitive Impairment

Keywords

Mediterranean diet; Western type diet; Olive oil polyphenols; Oleocanthal; Mild cognitive impairment; Alzheimer disease

Outcome Measures

Primary Outcomes (2)

• ADAS-Cog - Measurement to Assess the Severity of Cognitive Impairment

  Alzheimer's Disease Assessment Scale - Cognitive Subscale - 13 (ADAS-Cog-13) neuropsychological assessment scale scores ranges from 0 to 85, with greater scores showing a more significant cognitive impairment

  Baseline (Day 1) to 12 months

• MMSE - Measurement to Assess and Evaluate Cogntive Function

  Mini-Mental State Examination (MMSE) score ranges range from 0 to 30 and individuals will lower MMSE scores show greater cognitive impairment

  Baseline (Day 1) to 12 months

Secondary Outcomes (13)

• MoCA - Measurement to Assess Cognitive Abilities

  Baseline (Day 1) to 12 months

• ADCS-ADL-MCI - Measurement to Assess and Evaluate the Performance in Different Activities of Daily Living

  Baseline (Day 1) to 12 months

• CDR-SB - Measurement to Assess the Severity of the Disease and the Progression of the Disease

  Baseline (Day 1) to 12 months

• CDR - Measurement of Time to Progression to Dementia

  Baseline (Day 1) to 12 months

• GDS - Measurement to Identify Depression in the Elderly

  Baseline (Day 1) to 12 months

Other Outcomes (11)

• Measurment of Change in Plasma Aβ1-42

  Baseline (Day 1) to 12 months

• Measurment of Change in Plasma Aβ1-40

  Baseline (Day 1) to 12 months

• Measurement of Change in the Aβ1-42/Aβ1-40 Plasma Ratio

  Baseline (Day 1) to 12 months

Study Arms (4)

1st group

EXPERIMENTAL

50 participants will follow the MeDi pattern and will receive SUPOL for 12 months.

Dietary Supplement: SUPOL; Other: Dietary Pattern: MeDi

2nd group

PLACEBO COMPARATOR

50 participants will follow the MeDi pattern and will receive Placebo capsules for 12 months.

Other: Dietary Pattern: MeDi

3rd group

ACTIVE COMPARATOR

50 participants will follow the Western diet pattern and will receive SUPOL for 12 months.

Dietary Supplement: SUPOL

4th group

NO INTERVENTION

50 participants will follow the Western diet pattern and will receive Placebo capsules for 12 months.

Interventions

SUPOL DIETARY_SUPPLEMENT

Supplement containing Olive Oil Polyphenol with the main substance being Oleocanthal (SUPOL), 2 capsules twice a day (4 capsules total) for 12 months.

1st group; 3rd group

Dietary Pattern: MeDi OTHER

Adherance to Mediterranean dietary pattern to be followed for 12 months.

1st group; 2nd group

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants are eligible to be included in this study only if all the following criteria apply:
• Men or women,
• to 85 years of age inclusive, at the time of signing the informed consent form (ICF).
• Mini-Mental State Examination (MMSE) score of 26-28 at Screening (Visit 1).
• Montreal Cognitive Assessment (MoCA) score of 20-26 at Visit 1.
• MRI scan evaluation at Visit 1.
• CSF biomarkers evaluation at Visit 1.
• Adequate knowledge and understanding of the Greek language, as well as adequate literacy, vision and hearing for neuropsychological testing in the opinion of the Principal Investigator (PI) at the time of screening.
• They are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures.
• Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.

You may not qualify if:

• Participants are excluded from the study if any of the following criteria apply:
• Medical conditions
• Significant neurological diseases that affect the central nervous system other than MCI, that may affect cognition ability to complete the study, including but not limited to, other dementias, serious infection of the brain, Parkinson's disease (PD), Multiple sclerosis (MS), multiple concussions, epilepsy or recurrent seizures.
• Ongoing serious or unstable illnesses, including cardiovascular, hepatic, renal, gastroenterological, respiratory, endocrinologic, psychiatric, immunologic, hema-tologic diseases and other conditions that, in the PI's opinion, could interfere with the analyses in this study or has a life expectancy of less than 24 months.
• History of cancer within the last 5 years, with exception of non-metastatic basal and/or squamous cell carcinoma of the skin, in situ cervical cancer, nonprogressive prostate cancer, other cancers with low risk of recurrence or spread.
• Participants with any current primary psychiatric diagnosis, if in the judgement of the PI for the psychiatric disorder or symptom is likely to confound interpretation of the combined approach effect, affect cognitive assessment or affect the partici-pant's ability to complete the study. Participants with history of schizophrenia or other chronic psychosis are excluded.
• In the judgement of the PI, participants are actively suicidal and therefore deemed to be at significant risk of suicide.
• History of alcohol or drug abuse disorder (except tobacco use disorder) within 2 years before Visit 1.
• History of clinically significant multiple or severe drug allergies, significant atopy or severe post-treatment hypersensitivity reactions (including but not limited to erythema multiforme major, linear immunoglobulin A dermatosis, toxic epidermal necrolysis and/or exfoliative dermatitis).
• Patient has undergone surgical operation of the gastrointestinal tract (GI tract) that led to removal of a functional part of the GI tract, length shortage of the GI tract and change of the GI tract morphology.
• Imaging, Vital Signs, Laboratory Tests and Physical Examinations
• Any clinically important abnormality at Visit 1, as determined by the PI, in physical or neurological examination, vital signs or clinical laboratory test results, that could be detrimental to the participant, could compromise the study or show evidence of other etiologies for MCI.
• MRI which shows evidence of significant abnormality that would suggest another potential etiology for MCI or a clinically significant finding that may impact the participant's ability to safely participate in the study.
• Have any contraindications for MRI, including claustrophobia or the presence of contraindicated metal (ferromagnetic) implants/cardiac pacemaker.
• Poor venous access.

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead
• Greek Alzheimer's Association and Related Disorders: collaborator
• University of Glasgow: collaborator
• World Olive Center for Health: collaborator

Study Sites (2)

"AHEPA" General University Hospital of Thessaloniki

Thessaloniki, Thessaloniki, 54636, Greece

Location

Greek Association of Alzheimer's Disease and Related Disorders

Thessaloniki, Thessaloniki, 54643, Greece

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Alzheimer Disease

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This study will be single-blinded for the neuropsychological assessment evaluators regarding the dietary intervention and double-blinded for the participants and the neuropsychological assessment evaluators regarding the SUPOL intervention to minimise selection bias. The PI and the SUPOL supplier will be blinded to SUPOL administration for the proper conduct of this clinical study. If the PI deems medically necessary to reveal the participant's SUPOL or placebo allocation by breaking the blind, every possible effort must be made to keep participants and evaluators blinded until the end of intervention period.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Emeritus Professor Tsolaki Magdalini

Model Details: The overall design of the study will be a randomized 4-arm parallel controlled clinical trial, single-blinded for the dietary intervention (MeDi and Western diet) and double-blinded for the intervention (SUPOL and placebo).

Study Record Dates

• First Submitted: November 8, 2024
• First Posted: November 26, 2024
• Study Start: November 1, 2024
• Primary Completion: April 30, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: November 26, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

GR (2)