Effects of a Twenty-Four-Week Pomegranate Seed Oil Supplementation in Palliative Care Patients With Advanced Dementia: A Double Blind, Randomized Controlled Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Number of Palliative Care Patients with Advanced Dementia with Urinary Tract Infections (UTIs)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Pomegranate Seed Oil
干预措施: Pomegranate Seed Oil Supplementation in Palliative Care Patients with Advanced Dementia (Dietary Supplement)
Care-as-usual
干预措施: Care-as-usual (Other)
结局指标
主要结局
Number of Palliative Care Patients with Advanced Dementia with Urinary Tract Infections (UTIs)
时间窗: 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
Number of Palliative Care Patients with Advanced Dementia with Reccurent Urinary Tract Infections (rUTIs)
时间窗: 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.
次要结局
- 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)