The Role of Akkermansia Muciniphilia in Combating the Metabolic Effects of Androgen Deprivation Therapy in Men With Metastatic Prostate Cancer
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Fecal Akkermansia muciniphilia counts
研究概览
简要总结
The overriding objectives of this study are:
-
Primary outcomes:
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To confirm that administration of oral acetate increases the proportion of A. muciniphilia in the stool samples of patients with metastatic, castration-sensitive prostate cancer compared to a standard of care arm.
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To confirm tolerability and assess for side effects of oral acetate supplementation.
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Secondary outcomes:
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To determine if increased counts of A. muciniphilia correlate with improved metabolic parameters and improved bone health.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Apple Cider Vinegar
Jamison apple cider vinegar caplets (NPN: 80078433). Each patient will be instructed to take 1 acetate caplet (equivalent of 143 mg/caplet containing 36% acetic acid) per day for 3 months.
干预措施: Apple Cider Vinegar (Drug)
结局指标
主要结局
Fecal Akkermansia muciniphilia counts
时间窗: 6 month
Counts of Akkermansia muciniphilia in participant stool samples at 6 months following the intervention will be compared to baseline counts.
Side effects and tolerability
时间窗: 3 months
We will record side effects reported by the participants and the rate of Discontinuation of the intervention.
次要结局
- Metabolic parameters: fasting plasma glucose(6 months)
- Metabolic parameters: total cholesterol(6 months)
- Metabolic parameters: PSA(3 months)
- Metabolic parameters: hemoglobin(6 months)
- Metabolic parameters: HbA1C(3 months)
- Metabolic parameters: HbA1c(6 months)
- Metabolic parameters: triglycerides(6 months)
- Metabolic parameters: LDL cholesterol(6 months)
- Metabolic parameters: HDL cholesterol(6 months)
- Metabolic parameters: serum creatinine(3 months)
- Metabolic parameters: serum calcium(6 months)
- Metabolic parameters: alanine transferase(6 months)
- Metabolic parameters: aspartate aminotransferase(6 months)
- Metabolic parameters: Insulin resistance index (HOMA IR)(3 months)
- Metabolic parameters: HOMA IR(6 months)
- Bone health: dp-ucMGP levels(6 months)
- Bone health: Vitamin K2(6 months)
研究者
Melissa Huynh
Assistant Professor
Western University