Effects of Pomegranate Seed Oil and Mediterranean Diet on MCI

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

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.

Study Overview

• Status: Recruiting
• Conditions: Mild Cognitive Impairment
• Intervention / Treatment: Dietary supplement: Pomegranate oil, Mediterranean Diet; Dietary supplement: Mediterranean Diet

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Magda Tsolaki, MD PhD Prof.; Phone Number: 0030 2310 2411 56; Email: tsolakim1@gmail.com
• Study Contact Backup: Name: Thanos Chatzikostopoulos, MSc; Phone Number: 0030 2310351451; Email: thachatziko@gmail.com

Study Locations

• Greece
  • Thessaloniki
    • Thessaloníki, Thessaloniki, Greece
      • Recruiting
      • Alzheimer Hellas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 56 years to 81 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Dietary supplement: 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
Active Comparator: MD; Mediterranean Diet 30 patients Mediterranean dietary protocol Dietary Supplement: Mediterranean dietary protocol Intervention: Mediterranean diet	Dietary supplement: Mediterranean Diet; Dietary Supplement: Mediterranean dietary protocol

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Aristotle University Of Thessaloniki
• Collaborators: Greek Alzheimer's Association and Related Disorders
• Investigators: Study Chair: Magda Tsolaki, MD PhD Prof., Greek Alzheimer's Association and Related Disorders; Principal Investigator: Thanos Chatzikostopoulos, MSc, Greek Alzheimer's Association and Related Disorders

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Anticipated): June 30, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: July 26, 2021
• First Submitted That Met QC Criteria: July 26, 2021
• First Posted (Actual): August 4, 2021

Study Record Updates

• Last Update Posted (Estimate): December 14, 2022
• Last Update Submitted That Met QC Criteria: December 12, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Mental Health; Mild Cognitive Impairment; Cognition; APOE; ε3/ε3; ε3/ε2; ε3/ε4; ε2/ε4; ε4/ε4; Pomegranate oil
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: 69/5-6-2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Participants' personal data will not be shared with other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No