Effects of Pomegranate Seed Oil and Mediterranean Diet on MCI
NCT ID: NCT04990362
Last Updated: 2022-12-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2021-07-01
2023-12-31
Brief Summary
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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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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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MD + Seed oil
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
Pomegranate oil, Mediterranean Diet
Dietary Supplement: Pomegranate oil in a glass bottle of 0.15ml per day +Mediterranean dietary protocol Dietary Supplement: Mediterranean dietary protocol
MD
Mediterranean Diet 30 patients Mediterranean dietary protocol Dietary Supplement: Mediterranean dietary protocol Intervention: Mediterranean diet
Mediterranean Diet
Dietary Supplement: Mediterranean dietary protocol
Interventions
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Pomegranate oil, Mediterranean Diet
Dietary Supplement: Pomegranate oil in a glass bottle of 0.15ml per day +Mediterranean dietary protocol Dietary Supplement: Mediterranean dietary protocol
Mediterranean Diet
Dietary Supplement: Mediterranean dietary protocol
Eligibility Criteria
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Inclusion Criteria
* Carry APOE ε3 or ε4 genes
Exclusion Criteria
* Patients who receive medication for memory or depression
* Patients who do not carry APOE ε3 or ε4 genes
60 Years
85 Years
ALL
No
Sponsors
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Greek Alzheimer's Association and Related Disorders
OTHER
Aristotle University Of Thessaloniki
OTHER
Responsible Party
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Magda Tsolaki
Professor of Neurology, Medical School, Aristotle University of Thessaloniki Affiliation: Aristotle University of Thessaloniki
Principal Investigators
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Magda Tsolaki, MD PhD Prof.
Role: STUDY_CHAIR
Greek Alzheimer's Association and Related Disorders
Thanos Chatzikostopoulos, MSc
Role: PRINCIPAL_INVESTIGATOR
Greek Alzheimer's Association and Related Disorders
Locations
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Alzheimer Hellas
Thessaloniki, Thessaloniki, Greece
Countries
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Central Contacts
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Other Identifiers
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69/5-6-2021
Identifier Type: -
Identifier Source: org_study_id