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| Name | Class |
|---|---|
| Greek Alzheimer's Association and Related Disorders | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MD + Seed oil | Experimental | 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 |
|
| MD | Active Comparator | Mediterranean Diet 30 patients Mediterranean dietary protocol Dietary Supplement: Mediterranean dietary protocol Intervention: Mediterranean diet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pomegranate oil, Mediterranean Diet | Dietary Supplement | Dietary Supplement: Pomegranate oil in a glass bottle of 0.15ml per day +Mediterranean dietary protocol Dietary Supplement: Mediterranean dietary protocol |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Magda Tsolaki, MD PhD Prof. | Contact | 0030 2310 2411 56 | tsolakim1@gmail.com | |
| Thanos Chatzikostopoulos, MSc | Contact | 0030 2310351451 | thachatziko@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Magda Tsolaki, MD PhD Prof. | Greek Alzheimer's Association and Related Disorders | Study Chair |
| Thanos Chatzikostopoulos, MSc | Greek Alzheimer's Association and Related Disorders | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alzheimer Hellas | Recruiting | Thessaloniki | Thessaloniki | Greece |
Participants' personal data will not be shared with other researchers
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D010549 | Personal Satisfaction |
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| ID | Term |
|---|---|
| D038441 | Diet, Mediterranean |
| ID | Term |
|---|---|
| D000095500 | Diet, Plant-Based |
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
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| Mediterranean Diet | Dietary Supplement | Dietary Supplement: Mediterranean dietary protocol |
|
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 |
| D001519 |
| Behavior |
| D004032 |
| Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |