Effects of Pomegranate Seed Oil Supplementation in Patients With Advanced Dementia

February 18, 2026 updated by: Panhellenic Federation of Alzheimer's Disease and Related Disorders

Effects of a Twenty-Four-Week Pomegranate Seed Oil Supplementation in Palliative Care Patients With Advanced Dementia: A Double Blind, Randomized Controlled Clinical Study

The goal of this clinical study is to learn if Pomegranate Seed Oil supplementation works to combat urinary tract infections, recurrenturinary tract infections, or pneumonia and contributes to the tapering or discontinuation of antipsychotics in palliative care patients withadvanced dementia.

The main questions it aims to answer are:

  • Does Pomegranate Seed Oil supplementation reduce the likelihood of developing a urinary tract infection?
  • Does Pomegranate Seed Oil supplementation prevent UTI reinfection?
  • Does Pomegranate Seed Oil supplementation reduce the likelihood of pneumonia?
  • Does Pomegranate Seed Oil supplementation contribute to the tapering or discontinuation of antipsychotics?

Researchers will compare Pomegranate Seed Oil to care-as-usual to see if Pomegranate Seed Oil supplementation can increase quality of care in palliative care patients with advanced dementia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
    • Central Macedonia
      • Thessaloniki, Central Macedonia, Greece
        • Palliative Care Centre "Panagia Glykofilousa"

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Aged 65+
  • Dementia diagnosis (major neurocognitive disorder) according to the criteria Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) or the International Statistical Classification of Diseases and Related Health Problems (ICD-11)
  • Participants classified as Stage 7, Profound Cognitive Decline on the Global Deterioration Scale, corresponding to advanced dementia
  • AD related biomarkers in CSF
  • Caregiver consent for study participation

Exclusion Criteria:

  • History of allergy to the supplement or any of its components
  • Prior diagnosis of Schizophrenia Spectrum and Other Psychotic Disorders according to the criteria Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) or the International Statistical Classification of Diseases and Related Health Problems (ICD-11)
  • Participants having medical history of recurring urinary tract infections
  • Participants having medical history of renal or liver failure
  • Participants concurrently participating in other clinical studies

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pomegranate Seed Oil
Dietary supplement: Pomegranate Seed Oil Supplementation in Palliative Care Patients with Advanced Dementia
Besides Pomegranate Seed Oil Supplementation, all participants will continue to receive all ongoing care and treatments, including following the Mediterranean diet, monthly neuropsychological and behavioural assessments, physiotherapy, cognitive stimulation, occupational therapy and music therapy, without any modification
Other: Care-as-usual
Other: Care-as-usual
All participants will continue to receive all ongoing care and treatments, including a Mediterranean diet,monthly neuropsychological and behavioural assessments, physiotherapy, cognitive stimulation,occupational therapy and music therapy, without any modification

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Palliative Care Patients with Advanced Dementia with Urinary Tract Infections (UTIs)
Time Frame: From enrollment to the end of treatment at 24 weeks

Urinary Tract Infections were diagnosed using the revised McGeer criteria for the diagnosis of UTIs in Stone et al. (2012):

Criteria from both 1 and 2

  1. At least 1 of the following:

    Acute dysuria or acute pain, swelling, or tenderness of the testes, epididymis, or prostate OR

    Fever or leukocytosis and at least 1 of the following localizing urinary tract sub-criteria:

    Acute costovertebral angle pain or tenderness Suprapubic pain Gross hematuria New or marked increase in incontinence New or marked increase in urgency New or marked increase in frequency

    In the absence of fever or leukocytosis, then 2 or more of the following:

    Suprapubic pain Gross hematuria New or marked increase in incontinence New or marked increase in urgency New or marked increase in frequency

  2. One of the following:

At least 10^5 cfu/mL of no more than 2 species of microorganisms in a voided urine sample At least 10^2 of any number of organisms in a specimen collected by in-and-out catheter
From enrollment to the end of treatment at 24 weeks
Number of Palliative Care Patients with Advanced Dementia with Reccurent Urinary Tract Infections (rUTIs)
Time Frame: From enrollment to the end of treatment at 24 weeks
Recurrent UTIs were classified as more than one UTI diagnosed in a single patient based on the criteria proposed in Stone et al. (2012) as described previously.
From enrollment to the end of treatment at 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Palliative Care Patients with Advanced Dementia with Antipsychotic Deprescribing (Dose Reduction or Discontinuation)
Time Frame: From enrollment to the end of treatment at 24 weeks
From enrollment to the end of treatment at 24 weeks
Number of Palliative Care Patients with Advanced Dementia Diagnosed with Pneumonia
Time Frame: From enrollment to the end of treatment at 24 weeks

As in Stone et al. (2012):

All 3 criteria must be present:

  1. Interpretation of a chest radiograph as demonstrating pneumonia or the presence of a new infiltrate

  2. At least 1 of the following respiratory subcriteria

    1. New or increased cough
    2. New or increased sputum production
    3. O2 saturation <94% on room air or a reduction in O2 saturation of >3% from baseline
    4. New or changed lung examination abnormalities
    5. Pleuritic chest pain
    6. Respiratory rate of ≥25 breaths/min

  3. At least 1 of the following criteria

    1. Fever
    2. Leukocytosis
    3. Acute change in mental status from baseline and either disorganized thinking or altered level of consciousness
    4. Acute functional decline
From enrollment to the end of treatment at 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Panhellenic Federation of Alzheimer's Disease and Related Disorders

Collaborators

Greek Association of Alzheimer's Disease and Related Disorders (Alzheimer Hellas)
RODI HELLAS SA

Investigators

  • Study Chair: Magda Tsolaki, First Department of Neurology, Faculty of Health Sciences, School of Medicine, Aristotle University of Thessaloniki, Thessaloniki, Greece
  • Principal Investigator: Ilias Maliousis, Greek Association of Alzheimer's Disease and Related Disorders (Alzheimer Hellas)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Stone ND,Ashraf MS,Calder J,Crnich CJ,Crossley K,Drinka PJ,Gould CV,Juthani-Mehta M,Lautenbach E,Loeb M,Maccannell T,Malani PN,Mody L,Mylotte JM,Nicolle LE,Roghmann MC,Schweon SJ,Simor AE,Smith PW,Stevenson KB,Bradley SF,Society for Healthcare Epidemiology Long-Term Care Special Interest Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2024

Primary Completion (Actual)

October 31, 2024

Study Completion (Actual)

October 31, 2024

Study Registration Dates

First Submitted

February 8, 2026

First Submitted That Met QC Criteria

February 18, 2026

First Posted (Actual)

February 25, 2026

Study Record Updates

Last Update Posted (Actual)

February 25, 2026

Last Update Submitted That Met QC Criteria

February 18, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 96/6-3-24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data Availability Statement The data supporting the findings of this study will not be publicly available due to GAADRD's internal policy to maintain the privacy of research participants and patients. However, the data will be available on reasonable request from the corresponding author.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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