NCT06487507招募中不适用
Metabolic Impact and Compliance of Controlled, Varying, Mediterranean Diets in Pre-Surgical Prostate Cancer Populations (PROVISIONS)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Proportion of patients consuming Mediterranean diet
研究概览
简要总结
The study aims to investigate whether following a controlled Mediterranean-style diet prior to robotic-assisted radical prostatectomy surgery in patients diagnosed with prostate cancer affects fasting insulin levels and other values that can be measured in blood and tissue samples from surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Males 18 to 80 years old scheduled to undergo radical prostatectomy as per standard of care.
- •BMI between 18.5 and 40
- •Ability to read, write, speak, and understand English and/or Spanish.
- •Ability to provide informed consent.
- •Willingness to consume provided dietary interventions.
- •Adequate organ and marrow function as assessed by treating clinician(s) which includes: White blood cell count (WBC) ≥2,500/microliter. Absolute neutrophil count (ANC) ≥1,500/microliter. Platelets ≥100,000/microliter. Hemoglobin ≥9 g/dL (transfusions permitted) Total bilirubin ≤1.5 x the institutional upper limit of normal (ULN). For subjects with Gilbert's disease ≤3.0 mg/dL. Aspartate aminotransferase (AST)/Alanine aminotransferase (ALT) ≤2.5 x institutional ULN. Creatinine clearance ≥51 ml/min as defined by Cockcroft-Gault equation.
排除标准
- •Currently consuming a Mediterranean, lower carbohydrate, ketogenic, vegan, vegetarian, high fiber diet (14g fiber > per 1,000 Calories) and/or any supplements (including herbal), vitamins, minerals, that would interfere with diets being tested in the study as determined by dietitian and/or investigators as these diets are highly restrictive and may impact objectives/outcomes in the trial.
- •Previous intolerability to fiber-rich diets.
- •Colitis, Irritable Bowel Syndrome, or other gastrointestinal condition per clinician discretion.
- •Food allergies or other major dietary restrictions.
- •Receiving active medical treatment for Type I or Type II diabetes mellitus.
- •Recent weight loss or gain (both intentional and unintentional) as defined by 5%+ body weight in the last 30 days.
- •Undergone any type of weight loss surgery.
- •Any medical contraindications as determined by investigators.
- •History of diabetic ketoacidosis.
- •History of Gout.
- •Patients that are immunosuppressed (transplant history, on immunosuppression, etc.) as per clinician discretion.
- •Gallbladder removed or plan to remove per clinician evaluation.
- •Other malignancies actively receiving systemic treatment as per clinician evaluation.
- •Previous treatment for prostate cancer.
- •Previous history of pelvic radiation.
- •Patients with impaired decision-making capacity.
研究组 & 干预措施
Low Fat Diet Group
Experimental
Participants in this group will receive a low fat Mediterranean diet for 2 weeks.
干预措施: Low fat diet (Behavioral)
Lower Carbohydrate Mediterranean Diet Group
Experimental
Participants in this group will receive a lower carbohydrate Mediterranean diet for 2 weeks.
干预措施: Lower carbohydrate diet (Behavioral)
结局指标
主要结局
Proportion of patients consuming Mediterranean diet
时间窗: Up to 2 weeks
Defined as the proportion of patients who consumed greater than 80% of provided calories using diet records.
次要结局
- Change in high-sensitivity c-reactive protein(Baseline to 2 weeks)
- Change in fasting insulin(Baseline to 2 weeks)
- Change in fasting glucose(Baseline to 2 weeks)
- Change in blood pressure(Baseline to 2 weeks)
- Dietary behavior as measured by diet records questionnaire(Up to 2 weeks)
- Number of treatment related adverse events(Up to 2 weeks)
研究者
Nima Sharifi
Professor
University of Miami
研究点 (1)
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