Effects of Pomegranate Seed Oil and Mediterranean Diet on MCI

Study Overview
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Brief Summary
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A double-blind clinical trial of pomegranate oil and Mediterranean diet that will be carried out on 60 patients with Mild Cognitive Impairment (MCI) and APOE ε3 and ε4 allele. The aim of the research is to examine if the Mediterranean diet with pomegranate oil and without it can bring positive changes in patients with MCI in terms of motor and cognitive skills.

Detailed Description
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OBJECTIVES OF THE TRIAL The objectives of this study are: To investigate the efficacy of Mediterranean diet and Pomegranate oil as a disease course modifying treatment for MCI. STUDY DESIGN This is a Greek, controlled double-blind trial of two compared groups, one with Mediterranean diet and one with Mediterranean diet and pomegranate oil. Qualifying patients will be assigned to receive 0.15 mL of pomegranate oil every day with Mediterranean diet at one group and at the other group will not. A Mediterranean dietary protocol will be given on a daily basis for 12 months at both groups. Duration The total study duration will be 12 months. The recruitment will be about 6 months and the statistics and the preparation of the paper other 6 months. Number of Subjects: Sixty (60) subjects total will be enrolled.; Thirty (30) in the A group (Pomegranate oil + Mediterranean Diet); Thirty (30) in the B Group (Mediterranean Diet). Patient identification: Initials (First initial of first name and First initial of surname), date of birth and Patient Identification Number from database empedocles. Eligibility Screening Form (ESF) : Checklist of inclusion and exclusion criteria Eligibility Statement: for patients found to be ineligible, the reason for ineligibility must be stated and Written informed consent will be obtained from the subjects which are eligible. The informed consent form must be co-signed by the physician. The nature of the study and the potential risks associated with the trial will be explained to all subjects- candidates and their responsible informants. Signature and date: the ESF may be completed by a research assistant but it is required that the principal investigator/study clinician sign and date the ESF to verify eligibility of the patient for inclusion.

Official Title
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Effects of Pomegranate Seed Oil and Mediterranean Diet at Motor Skills and Cognitive Abilities in Mild Cognitive Impairment.

Conditions
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Mild Cognitive Impairment

Intervention / Treatment
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* Dietary Supplement: Pomegranate oil, Mediterranean Diet
* Dietary Supplement: Mediterranean Diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of Mild Cognitive Impairment Carry APOE ε3 or ε4 genes Exclusion Criteria: Diagnosis of Dementia Patients who receive medication for memory or depression Patients who do not carry APOE ε3 or ε4 genes

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MD + Seed oil<br>Pomegranate oil + Mediterranean Diet 30 patients Mediterranean dietary protocol Dietary Supplement: Pomegranate oil in a glass bottle of 30ml Dietary Supplement: Mediterranean dietary protocol Intervention: Mediterranean diet, Pomegranate oil | Dietary Supplement: Pomegranate oil, Mediterranean Diet<br>* Dietary Supplement: Pomegranate oil in a glass bottle of 0.15ml per day +Mediterranean dietary protocol Dietary Supplement: Mediterranean dietary protocol<br>|
| Active Comparator: MD<br>Mediterranean Diet 30 patients Mediterranean dietary protocol Dietary Supplement: Mediterranean dietary protocol Intervention: Mediterranean diet | Dietary Supplement: Mediterranean Diet<br>* Dietary Supplement: Mediterranean dietary protocol<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mini-Mental State Examination (MMSE | Score scale:0-30,cut off:24 | baseline,12 months | 
| FUCAS | Measurements to Assess Daily Functionality Changes in Functional cognitive assessment scale (FUCAS) score Score scale:42-126,cut off:42 | baseline,12 months | 
| Letter & Category Fluency Test | Measurement to Assess Verbal Fluency and Learning Changes in the Letter & Category Fluency Test | baseline,12 months | 
| CDR | Measurements to Assess General Cognitive Function Changes in Global Clinical Dementia Rating (CDR) | baseline,12 months | 
| MoCA | Measurements to Assess General Cognitive Function Changes in Montreal Cognitive Assessment (MoCA) | baseline,12 months | 
| CANTAB | Measurements to Assess General Cognitive Function Changes in Cambridge Neuropsychological Test Automated Battery (CANTAB) | baseline,12 months | 
| Clock Drawing test | Measurements to Assess General Cognitive Function Changes in the Clock Drawing test | baseline,12 months | 
| Logical Memory test | Measurements to Assess General Cognitive Function Changes in the Logical Memory test | baseline,12 months | 
| Digit Span Forward & Backward test | Measurements to Assess General Cognitive Function Changes in the Digit Span Forward & Backward test | baseline,12 months | 
| WAIS-R Digit Symbol | Measurements to Assess General Cognitive Function Changes in the WAIS-R Digit Symbol Substitution Test | baseline,12 months | 
| TMT part A and B | Measurements to Assess General Cognitive Function Changes in the Trail Making Test | baseline,12 months | 
| ADASCog | Measurements to Assess Daily Functionality Changes in Alzheimer's Disease Assessment Scale-Cognitive (ADASCog) | baseline,12 months | 
| Functional Rating Scale for Dementia | Measurements to Assess Daily Functionality Changes in Functional Rating Scale for Dementia (FRSSD) | baseline,12 months | 
| Auditory Verbal Learning Test | Measurement to Assess Verbal Fluency and Learning Changes in the Auditory Verbal Learning Test | baseline,12 months | 
| Boston Naming Test | Measurement to Assess Verbal Fluency and Learning Changes in the Boston Naming Test | baseline,12 months | 
| Fullerton Functional Test | Measurement to Assess Physical Abilities | baseline,12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognition, Mild Cognitive Impairment, Mental Health, APOE, ε3/ε3, ε3/ε2, ε3/ε4, ε2/ε4, ε4/ε4, Pomegranate oil