The Effect of Combination of Mediterranean Diet and Oleocanthal in Patients with Mild Cognitive Impairment
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Mild Cognitive Impairment
- Sponsor
- Aristotle University Of Thessaloniki
- Enrollment
- 200
- Locations
- 2
- Primary Endpoint
- ADAS-Cog - Measurement to Assess the Severity of Cognitive Impairment
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
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.
Detailed Description
OBJECTIVE OF THE TRIAL: To evaluate the efficacy of the combined approach of the MeDi pattern and the concurrent SUPOL compared to the Western diet pattern in combination with placebo on the change in cognition and function in subjects with MCI. STUDY DESIGN: The design will be a randomized parallel controlled clinical trial, single-blinded for the dietary pattern and double-blinded for the intervention. PARTICIPANTS: They will be divided into 4 groups of 50 (n=200): 1st group following MeDi and receiving SUPOL, 2nd group following MeDi and receiving Placebo, 3rd group following Western type diet (Western diet) and receiving SUPOL and 4th group following Western diet and receiving Placebo. DURATION: The duration of the combined intervention will be 12 months and the neuropsychological and laboratory evaluation of the participants will take place at baseline and upon the completion of the 1-year combined intervention. A follow-up assessment visit will be perfomed after 6 monts. The total study duration will be 18 months. LOCATION: The study will be conducted in Thessaloniki and will recruit patients having diagnosed with MCI from the outpatient clinic 1st Neurological Clinic of the General University Hospital "AHEPA" (AHEPA) and the Greek Association of Alzheimer's Disease and Related Disorders (Alzheimer Hellas). SCREENING - RANDOMIZATION - BASELINE (Visit 1): Patient eligibility will be determined during Visit 1. A protocol eligibility form will be completed for each patient and reviewed by the Principal Investigator (PI) approval prior to participation in the study. If eligibility is reached, baseline assessments, as well as randomization for group allocation will take place.
Investigators
Magda Tsolaki
Emeritus Professor Tsolaki Magdalini
Aristotle University Of Thessaloniki
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •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
- •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.
Outcomes
Primary Outcomes
ADAS-Cog - Measurement to Assess the Severity of Cognitive Impairment
Time Frame: Baseline (Day 1) to 12 months
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
MMSE - Measurement to Assess and Evaluate Cogntive Function
Time Frame: Baseline (Day 1) to 12 months
Mini-Mental State Examination (MMSE) score ranges range from 0 to 30 and individuals will lower MMSE scores show greater cognitive impairment
Secondary Outcomes
- 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)
- C-SSRS - Measurement to Determine the Potential Risk for Suicide(Baseline (Day 1) to 12 months)
- TEAEs - Measurment of Number of Treatment Emergent Adverse Events(Baseline (Day 1) to 12 months)
- Measurement of Change in the Vital Signs(Baseline (Day 1) to 12 months)
- Measurement of Change in Physical Examination(Baseline (Day 1) to 12 months)
- Measurement of Change in Neurological Examination(Baseline (Day 1) to 12 months)
- Measurment of Change in Clinical Laboratory Tests(Baseline (Day 1) to 12 months)
- Measurement of Change in Clinical Laboratory Tests(Baseline (Day 1) to 12 months)