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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 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.
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 (2)
Loading locations...
相似试验
进行中（未招募）
不适用
Metabolomics Initiative: Mediterranean-amplified vs Habitual Western Diet on Food Signatures, Health, and MicrobiomeDietary HabitsNCT05500976University of Colorado, Denver22
招募中
不适用
Mediterranean Diet Post-liver TransplantationLiver TransplantationNCT04672863Mayo Clinic80
招募中
不适用
Impact of Mediterranean Diet in Cardiovascular Risk Among People With HIVHIV InfectionInflammationCardiovascular RiskMediterranean DietNCT06757309Parc de Salut Mar64
Unknown
不适用
Effect of Mediterranean Diet in Dyslipidemic PatientsDyslipidemiasNCT04486664Gangnam Severance Hospital100
已完成
不适用
Evaluation of the Effect of Mediterranean Diet on Breast Cancer PatientsBreast CancerNCT04818996Aydin Adnan Menderes University25