Effects of Pomegranate Seed Oil Supplementation in Patients With Advanced Dementia

NCT07432763 | Completed DMC

• 1 other identifier: 96/6-3-24
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Urinary Tract Infections (UTIs); Urinary Tract Infection, Recurrent; Antipsychotics Discontinuation; Antipsychotics Tapering

Keywords

Pomegranate Seed Oil; Mediterranean Diet; Palliative Care; Advanced Dementia; Patient Safety; Urinary Tract Infections; Antipsychotics; Randomized Clinical Trial

Outcome Measures

Primary Outcomes (2)

• 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

  From enrollment to the end of treatment at 24 weeks

• 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.

  From enrollment to the end of treatment at 24 weeks

Secondary Outcomes (2)

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

  From enrollment to the end of treatment at 24 weeks

• Number of Palliative Care Patients with Advanced Dementia Diagnosed with Pneumonia

  From enrollment to the end of treatment at 24 weeks

Study Arms (2)

Pomegranate Seed Oil

EXPERIMENTAL

Dietary Supplement: Pomegranate Seed Oil Supplementation in Palliative Care Patients with Advanced Dementia

Care-as-usual

OTHER

Other: Care-as-usual

Interventions

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

Pomegranate Seed Oil

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

Care-as-usual

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Panhellenic Federation of Alzheimer's Disease and Related Disorders: lead
• Greek Association of Alzheimer's Disease and Related Disorders (Alzheimer Hellas): collaborator
• RODI HELLAS SA: collaborator

Study Sites (1)

Palliative Care Centre "Panagia Glykofilousa"

Thessaloniki, Central Macedonia, Greece

Location

Related Publications (1)

• 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.

  PMID: 22961014 BACKGROUND

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Magda Tsolaki

  First Department of Neurology, Faculty of Health Sciences, School of Medicine, Aristotle University of Thessaloniki, Thessaloniki, Greece

  STUDY CHAIR

• Ilias Maliousis

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2026
• First Posted: February 25, 2026
• Study Start: May 1, 2024
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2024
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)