NCT04990362

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.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Aristotle University Of Thessaloniki · Academic / Other
• Sex: All
• Age: 60 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Mild Cognitive Impairment

Interventions

Type	Name	Description
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
DIETARY_SUPPLEMENT	Mediterranean Diet	Dietary Supplement: Mediterranean dietary protocol

Timeline

• Start date: 2021-07-01
• Primary completion: 2023-06-30
• Completion: 2023-12-31
• First posted: 2021-08-04
• Last updated: 2022-12-14

Locations

1 site across 1 country: Greece