Effects of Pomegranate Seed Oil and Mediterranean Diet on MCI

Not Applicable

Recruiting

• Conditions: Mild Cognitive Impairment
• Interventions: Dietary Supplement: Mediterranean Diet; Dietary Supplement: Pomegranate oil, Mediterranean Diet

• Registration Number: NCT04990362
• Lead Sponsor: Aristotle University Of Thessaloniki

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.

Study Timeline

• Study Start: 2021-07-01
• Study First Submitted: 2021-07-26
• Study First Submitted QC: 2021-07-26
• Study First Posted: 2021-08-04
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-12
• Last Update Posted: 2022-12-14
• Primary Completion: 2023-06-30
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MD	Mediterranean Diet	Mediterranean Diet 30 patients Mediterranean dietary protocol Dietary Supplement: Mediterranean dietary protocol Intervention: Mediterranean diet
MD + Seed oil	Pomegranate oil, Mediterranean Diet	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

Primary Outcome Measures

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

Trial Locations

Locations (1)

Alzheimer Hellas; 🇬🇷 Thessaloníki, Thessaloniki, Greece