Mild Cognitive ImpairmentNCT04990362
Effects of Pomegranate Seed Oil and Mediterranean Diet on MCI
A study testing Pomegranate oil, Mediterranean Diet and Mediterranean Diet in people with Mild Cognitive Impairment, run by Aristotle University Of Thessaloniki at 1 site in Greece.
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… Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Pomegranate oil, Mediterranean Diet and Mediterranean Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGreece
- Study dates
- 1 Jul 2021to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Mild Cognitive Impairment
- Carry APOE ε3 or ε4 genes
Who cannot join
- Diagnosis of Dementia
- Patients who receive medication for memory or depression
- Patients who do not carry APOE ε3 or ε4 genes
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
Alzheimer Hellas
Thessaloniki, Thessaloniki
About this study
Official title: 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.
Read the 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
- Being tested
- Pomegranate oil, Mediterranean Diet, Mediterranean Diet
- Keywords
- Mild Cognitive Impairment, Cognition, Mental Health, APOE, ε3/ε3, ε3/ε2, ε3/ε4, ε2/ε4, ε4/ε4, Pomegranate oil
- Medical subject headings
- Cognitive Dysfunction, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pomegranate oil, Mediterranean DietDietary supplement
Dietary Supplement: Pomegranate oil in a glass bottle of 0.15ml per day +Mediterranean dietary protocol Dietary Supplement: Mediterranean dietary protocol
Mediterranean DietDietary supplement
Dietary Supplement: Mediterranean dietary protocol
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Dietary Supplement: Pomegranate oil, Mediterranean Diet |
| MD | Active comparator | Mediterranean Diet 30 patients Mediterranean dietary protocol Dietary Supplement: Mediterranean dietary protocol Intervention: Mediterranean diet Receives: Dietary Supplement: Mediterranean Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mini-Mental State Examination (MMSE
Score scale:0-30,cut off:24
Measured: baseline,12 months
FUCAS
Measurements to Assess Daily Functionality Changes in Functional cognitive assessment scale (FUCAS) score Score scale:42-126,cut off:42
Measured: baseline,12 months
Letter & Category Fluency Test
Measurement to Assess Verbal Fluency and Learning Changes in the Letter \& Category Fluency Test
Measured: baseline,12 months
CDR
Measurements to Assess General Cognitive Function Changes in Global Clinical Dementia Rating (CDR)
Measured: baseline,12 months
MoCA
Measurements to Assess General Cognitive Function Changes in Montreal Cognitive Assessment (MoCA)
Measured: baseline,12 months
CANTAB
Measurements to Assess General Cognitive Function Changes in Cambridge Neuropsychological Test Automated Battery (CANTAB)
Measured: baseline,12 months
Clock Drawing test
Measurements to Assess General Cognitive Function Changes in the Clock Drawing test
Measured: baseline,12 months
Logical Memory test
Measurements to Assess General Cognitive Function Changes in the Logical Memory test
Measured: baseline,12 months
Digit Span Forward & Backward test
Measurements to Assess General Cognitive Function Changes in the Digit Span Forward \& Backward test
Measured: baseline,12 months
WAIS-R Digit Symbol
Measurements to Assess General Cognitive Function Changes in the WAIS-R Digit Symbol Substitution Test
Measured: baseline,12 months
TMT part A and B
Measurements to Assess General Cognitive Function Changes in the Trail Making Test
Measured: baseline,12 months
ADASCog
Measurements to Assess Daily Functionality Changes in Alzheimer's Disease Assessment Scale-Cognitive (ADASCog)
Measured: baseline,12 months
Functional Rating Scale for Dementia
Measurements to Assess Daily Functionality Changes in Functional Rating Scale for Dementia (FRSSD)
Measured: baseline,12 months
Auditory Verbal Learning Test
Measurement to Assess Verbal Fluency and Learning Changes in the Auditory Verbal Learning Test
Measured: baseline,12 months
Boston Naming Test
Measurement to Assess Verbal Fluency and Learning Changes in the Boston Naming Test
Measured: baseline,12 months
Fullerton Functional Test
Measurement to Assess Physical Abilities
Measured: baseline,12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2021
- Study start1 Jul 2021
- Primary completion30 Jun 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Aristotle University Of ThessalonikiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Collaborators
- Greek Alzheimer's Association and Related Disorders
- Responsible party
- Principal investigator, Magda Tsolaki, Aristotle University Of Thessaloniki
- Investigators
- Magda Tsolaki, MD PhD Prof., Study chair, Greek Alzheimer's Association and Related DisordersThanos Chatzikostopoulos, MSc, Principal investigator, Greek Alzheimer's Association and Related Disorders
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04990362
- Sponsor's protocol ID
- 69/5-6-2021
- Status last verified
- Dec 2022
- First submitted
- 26 Jul 2021
- Last updated
- 14 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participants' personal data will not be shared with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pomegranate Seed Oil and Mediterranean Diet at Motor Skills and Cognitive Abilities in Mild Cognitive Impairment.
- ClinicalTrials.gov ID
- NCT04990362
- Acronym / sponsor ID
- 69/5-6-2021
- Conditions
- Mild Cognitive Impairment
- Keywords
- Mild Cognitive Impairment, Cognition, Mental Health, APOE, ε3/ε3, ε3/ε2, ε3/ε4, ε2/ε4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Collaborators
- Greek Alzheimer's Association and Related Disorders
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 4 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MD + Seed oil | Experimental | Dietary Supplement: Pomegranate oil, Mediterranean DietPomegranate 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 |
| MD | Active comparator | Dietary Supplement: Mediterranean DietMediterranean Diet 30 patients Mediterranean dietary protocol Dietary Supplement: Mediterranean dietary protocol Intervention: Mediterranean diet |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of Mild Cognitive Impairment
- Carry APOE ε3 or ε4 genes
Key exclusion criteria (3 listed)
- Diagnosis of Dementia
- Patients who receive medication for memory or depression
- Patients who do not carry APOE ε3 or ε4 genes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pomegranate oil, Mediterranean DietDietary Supplement: Pomegranate oil in a glass bottle of 0.15ml per day +Mediterranean dietary protocol Dietary Supplement: Mediterranean dietary protocol | Dietary supplement | MD + Seed oil |
| Mediterranean DietDietary Supplement: Mediterranean dietary protocol | Dietary supplement | MD |
Primary outcome
Mini-Mental State Examination (MMSE
Time frame: baseline,12 months
Score scale:0-30,cut off:24
FUCAS
Time frame: 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
Time frame: baseline,12 months
Measurement to Assess Verbal Fluency and Learning Changes in the Letter \& Category Fluency Test
CDR
Time frame: baseline,12 months
Measurements to Assess General Cognitive Function Changes in Global Clinical Dementia Rating (CDR)
MoCA
Time frame: baseline,12 months
Measurements to Assess General Cognitive Function Changes in Montreal Cognitive Assessment (MoCA)
CANTAB
Time frame: baseline,12 months
Measurements to Assess General Cognitive Function Changes in Cambridge Neuropsychological Test Automated Battery (CANTAB)
Clock Drawing test
Time frame: baseline,12 months
Measurements to Assess General Cognitive Function Changes in the Clock Drawing test
Logical Memory test
Time frame: baseline,12 months
Measurements to Assess General Cognitive Function Changes in the Logical Memory test
Digit Span Forward & Backward test
Time frame: baseline,12 months
Measurements to Assess General Cognitive Function Changes in the Digit Span Forward \& Backward test
WAIS-R Digit Symbol
Time frame: baseline,12 months
Measurements to Assess General Cognitive Function Changes in the WAIS-R Digit Symbol Substitution Test
TMT part A and B
Time frame: baseline,12 months
Measurements to Assess General Cognitive Function Changes in the Trail Making Test
ADASCog
Time frame: baseline,12 months
Measurements to Assess Daily Functionality Changes in Alzheimer's Disease Assessment Scale-Cognitive (ADASCog)
Functional Rating Scale for Dementia
Time frame: baseline,12 months
Measurements to Assess Daily Functionality Changes in Functional Rating Scale for Dementia (FRSSD)
Auditory Verbal Learning Test
Time frame: baseline,12 months
Measurement to Assess Verbal Fluency and Learning Changes in the Auditory Verbal Learning Test
Boston Naming Test
Time frame: baseline,12 months
Measurement to Assess Verbal Fluency and Learning Changes in the Boston Naming Test
Fullerton Functional Test
Time frame: baseline,12 months
Measurement to Assess Physical Abilities
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2022.
- Individual participant dataSharing planned: No. Participants' personal data will not be shared with other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Magda Tsolaki, MD PhD Prof. study chair
Greek Alzheimer's Association and Related Disorders
Thanos Chatzikostopoulos, MSc principal investigator
Greek Alzheimer's Association and Related Disorders
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pomegranate oil, Mediterranean Diet and Mediterranean Diet in people with Mild Cognitive Impairment, run by Aristotle University Of Thessaloniki at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Magda Tsolaki, MD PhD Prof. (0030 2310 2411 56, tsolakim1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mini-Mental State Examination (MMSE (time frame: baseline,12 months). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2022.