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Completed

NCT Number: NCT07432763

Effects of Pomegranate Seed Oil Supplementation in Patients With Advanced Dementia

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Palliative Care Centre "Panagia Glykofilousa"

Thessaloniki, Central Macedonia, Greece

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pomegranate Seed Oil Supplementation in Palliative Care Patients with Advanced Dementia

Dietary 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-usual

Other

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

Primary outcomes

  1. 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

    • 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

    • 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

  2. 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.

Secondary outcomes

  1. 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

  2. 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:

    • Interpretation of a chest radiograph as demonstrating pneumonia or the presence of a new infiltrate
    • At least 1 of the following respiratory subcriteria
    • New or increased cough
    • New or increased sputum production
    • O2 saturation <94% on room air or a reduction in O2 saturation of >3% from baseline
    • New or changed lung examination abnormalities
    • Pleuritic chest pain
    • Respiratory rate of ≥25 breaths/min
    • At least 1 of the following criteria
    • Fever
    • Leukocytosis
    • Acute change in mental status from baseline and either disorganized thinking or altered level of consciousness
    • Acute functional decline

Sponsors and collaborators

Lead sponsor

Panhellenic Federation of Alzheimer's Disease and Related Disorders

Other

Collaborators

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

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Feb 25, 2026
Registry last updated
Feb 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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