Effects of Pomegranate Seed Oil and Mediterranean Diet on MCI

Mild Cognitive Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04990362
• Other study ID #: 69/5-6-2021
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: December 2022
• Source: Aristotle University Of Thessaloniki
• Contact: Magda Tsolaki, MD PhD Prof.
• Phone: 0030 2310 2411 56
• Email: tsolakim1[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 85 Years

Eligibility

Inclusion Criteria:

• Diagnosis of Mild Cognitive Impairment

• Carry APOE e3 or e4 genes

Exclusion Criteria:

• Diagnosis of Dementia

• Patients who receive medication for memory or depression

• Patients who do not carry APOE e3 or e4 genes

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

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
• Mediterranean Diet
Dietary Supplement: Mediterranean dietary protocol

Locations

Country	Name	City	State
Greece	Alzheimer Hellas	Thessaloníki	Thessaloniki

Sponsors (2)

Lead Sponsor	Collaborator
Aristotle University Of Thessaloniki	Greek Alzheimer's Association and Related Disorders

Country where clinical trial is conducted

Greece, 

Outcome

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