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Urinary Tract Infections (UTIs)NCT07432763

Effects of Pomegranate Seed Oil Supplementation in Patients With Advanced Dementia

A study testing Pomegranate Seed Oil Supplementation in Palliative Care Patients with Advanced Dementia and Care-as-usual in people with Urinary Tract Infections (UTIs) and Urinary Tract Infection, Recurrent, run by Panhellenic Federation of Alzheimer's Disease and Related Disorders at 1 site in Greece.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 65 years and older
What is being tested?
Pomegranate Seed Oil Supplementation in Palliative Care Patients with Advanced Dementia and Care-as-usual
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteGreece
Study dates
1 May 2024to 31 Oct 2024
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 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Greece1 site

  • Palliative Care Centre "Panagia Glykofilousa"

    Thessaloniki, Central Macedonia

Other trials in Greece

About this study

Official title: 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:

Read more
  • 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.

Being tested
Pomegranate Seed Oil Supplementation in Palliative Care Patients with Advanced Dementia, Care-as-usual
Keywords
Pomegranate Seed Oil, Mediterranean Diet, Palliative Care, Advanced Dementia, Patient Safety, Urinary Tract Infections, Antipsychotics, Randomized Clinical Trial
Medical subject headings
Urinary Tract Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pomegranate Seed Oil Supplementation in Palliative Care Patients with Advanced DementiaDietary supplement

    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

  • Care-as-usualOther

    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

Study groups in NCT07432763
Study groupRoleWhat they receive
Pomegranate Seed OilExperimentalNot described
Receives: Dietary Supplement: Pomegranate Seed Oil Supplementation in Palliative Care Patients with Advanced Dementia
Care-as-usualOtherNot described
Receives: Other: Care-as-usual

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Palliative Care Patients with Advanced Dementia with Urinary Tract Infections (UTIs)

    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

    Measured: From enrollment to the end of treatment at 24 weeks

  2. Number of Palliative Care Patients with Advanced Dementia with Reccurent Urinary Tract Infections (rUTIs)

    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.

    Measured: From enrollment to the end of treatment at 24 weeks

Secondary outcomes (2)

  1. Number of Palliative Care Patients with Advanced Dementia with Antipsychotic Deprescribing (Dose Reduction or Discontinuation)

    Measured: From enrollment to the end of treatment at 24 weeks

  2. Number of Palliative Care Patients with Advanced Dementia Diagnosed with Pneumonia

    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
    3. New or increased cough
    4. New or increased sputum production
    5. O2 saturation <94% on room air or a reduction in O2 saturation of >3% from baseline
    6. New or changed lung examination abnormalities
    7. Pleuritic chest pain
    8. Respiratory rate of ≥25 breaths/min
    9. At least 1 of the following criteria
    10. Fever
    11. Leukocytosis
    12. Acute change in mental status from baseline and either disorganized thinking or altered level of consciousness
    13. Acute functional decline

    Measured: From enrollment to the end of treatment at 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Feb 2026
  2. Study start1 May 2024
  3. Primary completion31 Oct 2024
  4. Study completion31 Oct 2024

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07432763
Sponsor's protocol ID
96/6-3-24
Status last verified
Feb 2026
First submitted
8 Feb 2026
Last updated
25 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

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. Surveillance definitions of infections in long-term care facilities: revisiting the McGeer criteria. Infect Control Hosp Epidemiol. 2012 Oct;33(10):965-77. doi: 10.1086/667743.

    PubMed 22961014

Questions about this trial

What is this clinical trial studying?

A study testing Pomegranate Seed Oil Supplementation in Palliative Care Patients with Advanced Dementia and Care-as-usual in people with Urinary Tract Infections (UTIs) and Urinary Tract Infection, Recurrent, run by Panhellenic Federation of Alzheimer's Disease and Related Disorders 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 5 inclusion and 5 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: finished, as of the sponsor's last update on 25 Feb 2026. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07432763, which also lists 1 linked publication.

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 25 Feb 2026.

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