Effects of Pomegranate Seed Oil and Mediterranean Diet on MCI

NCT04990362 | Unknown DMC

• 1 other identifier: 69/5-6-2021
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Cognitive Impairment

Keywords

Mild Cognitive Impairment; Cognition; Mental Health; APOE; ε3/ε3; ε3/ε2; ε3/ε4; ε2/ε4; ε4/ε4; Pomegranate oil

Outcome Measures

Primary Outcomes (16)

• 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

Study Arms (2)

MD + Seed oil

EXPERIMENTAL

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

MD

ACTIVE COMPARATOR

Mediterranean Diet 30 patients Mediterranean dietary protocol Dietary Supplement: Mediterranean dietary protocol Intervention: Mediterranean diet

Dietary Supplement: Mediterranean Diet

Interventions

Pomegranate oil, Mediterranean Diet DIETARY_SUPPLEMENT

Dietary Supplement: Pomegranate oil in a glass bottle of 0.15ml per day +Mediterranean dietary protocol Dietary Supplement: Mediterranean dietary protocol

MD + Seed oil

Mediterranean Diet DIETARY_SUPPLEMENT

Dietary Supplement: Mediterranean dietary protocol

MD

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Mild Cognitive Impairment
• Carry APOE ε3 or ε4 genes

You may not qualify if:

• Diagnosis of Dementia
• Patients who receive medication for memory or depression
• Patients who do not carry APOE ε3 or ε4 genes

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead
• Greek Alzheimer's Association and Related Disorders: collaborator

Study Sites (1)

Alzheimer Hellas

Thessaloniki, Thessaloniki, Greece

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction; Psychological Well-Being

Interventions

Diet, Mediterranean

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Personal Satisfaction; Behavior

Intervention Hierarchy (Ancestors)

Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Magda Tsolaki, MD PhD Prof.

  Greek Alzheimer's Association and Related Disorders

  STUDY CHAIR

• Thanos Chatzikostopoulos, MSc

  Greek Alzheimer's Association and Related Disorders

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Magda Tsolaki, MD PhD Prof.

CONTACT

0030 2310 2411 56; tsolakim1@gmail.com

Thanos Chatzikostopoulos, MSc

CONTACT

0030 2310351451; thachatziko@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurology, Medical School, Aristotle University of Thessaloniki Affiliation: Aristotle University of Thessaloniki

Study Record Dates

• First Submitted: July 26, 2021
• First Posted: August 4, 2021
• Study Start: July 1, 2021
• Primary Completion: June 30, 2023
• Study Completion: December 31, 2023
• Last Updated: December 14, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)