Clinical trial NCT04990362: Effects of Pomegranate Seed Oil and Mediterranean Diet on MCI
Official title: Effects of Pomegranate Seed Oil and Mediterranean Diet at Motor Skills and Cognitive Abilities in Mild Cognitive Impairment.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mild Cognitive Impairment
Keywords: Mild Cognitive Impairment
Cognition
Mental Health
APOE
ε3/ε3
ε3/ε2
ε3/ε4
ε2/ε4
ε4/ε4
Pomegranate oil
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
Collaborators: name: Greek Alzheimer's Association and Related Disorders
First posted: 2021-08-04
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Mini-Mental State Examination (MMSE
timeFrame: baseline,12 months
measure: FUCAS
timeFrame: baseline,12 months
measure: Letter & Category Fluency Test
timeFrame: baseline,12 months
measure: CDR
timeFrame: baseline,12 months
measure: MoCA
timeFrame: baseline,12 months
measure: CANTAB
timeFrame: baseline,12 months
measure: Clock Drawing test
timeFrame: baseline,12 months
measure: Logical Memory test
timeFrame: baseline,12 months
measure: Digit Span Forward & Backward test
timeFrame: baseline,12 months
measure: WAIS-R Digit Symbol
timeFrame: baseline,12 months
measure: TMT part A and B
timeFrame: baseline,12 months
measure: ADASCog
timeFrame: baseline,12 months
measure: Functional Rating Scale for Dementia
timeFrame: baseline,12 months
measure: Auditory Verbal Learning Test
timeFrame: baseline,12 months
measure: Boston Naming Test
timeFrame: baseline,12 months
measure: Fullerton Functional Test
timeFrame: baseline,12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Thessaloníki
country: Greece
facility: Alzheimer Hellas
state: Thessaloniki
Study officials:
affiliation: Greek Alzheimer's Association and Related Disorders
name: Magda Tsolaki, MD PhD Prof.
role: STUDY_CHAIR
affiliation: Greek Alzheimer's Association and Related Disorders
name: Thanos Chatzikostopoulos, MSc
role: PRINCIPAL_INVESTIGATOR
References: