Elucidating the Metabolic Impact of Isocaloric, Controlled, Mediterranean-Type Diets in Treatment-Naïve Men With Prostate Cancer on Active Surveillance (DINE Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Evaluate the impact of Med-t-Diets on non-malignant prostate tissue metabolism
研究概览
简要总结
The purpose of this study is to examine the impact of Mediterranean-type diets on the metabolism of men with localized prostate cancer.
The optimal diet for men with a suspected diagnosis of Prostate Cancer (PCa) is currently unknown. More specifically, the suggested benefits of low carbohydrate and low fat diets in PCa are not determined.
详细描述
Primary Objective
-Evaluate the impact of Mediterranean diets (Med-t-Diets) on non-malignant prostate tissue metabolism
Secondary Objectives
- Evaluate the impact of Med-t-Diets on host metabolism
- Evaluate the impact of Med-t-Diets on systemic biomarkers after consuming Med-t-Diets
- Evaluate the impact of Med-t-Diets on the microbiome and dietary behavior and compliance after consuming Med-t-Diets
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
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
- •Males ≥18 years old
- •High suspicion of prostate cancer (PCa) per urologist's clinical evaluation
- •BMI >18.5
- •No prior PCa diagnosis or hormonal therapy (-ies)
- •Ability to read, write, speak, and understand English
- •Ability to provide informed consent
- •Candidate for and elects active surveillance (AS) if diagnostic biopsy is positive
- •Willingness to consume provided dietary interventions
- •Adequate organ and marrow function: White blood cell count (WBC) ≥2,500/mcL, Absolute neutrophil count (ANC) ≥1,500/mcL, Platelets ≥100,000/mcL, 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.
- •Previous intolerability to fiber-rich diets
- •Colitis, Irritable Bowel Syndrome, or other gastrointestinal condition per clinician discretion
- •Unwilling to undergo transperineal PCa biopsies
- •Food allergies or other major dietary restrictions
- •Receiving active medical treatment for Type I or Type II diabetes mellitus
- •Prior antibiotic usage (i.e. within last 30 days) at time of consent
- •Recent weight loss (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
- •High risk as defined by PSA≥20 and/or PI-RADS 5 lesion as per clinician evaluation
- •History of diabetic ketoacidosis
- •Patients that are immunosuppressed (transplant history, on immunosuppression, etc.) as per clinician discretion
- •Recent (within last 30 days) device implant/joint requiring antibiotics as per clinician determination
- •Prior history of prostate biopsy infection
- •Uncontrolled hypertension as defined by blood pressure greater than 140/80 (with or without medication)
- •Gallbladder removed or plan to remove per clinician evaluation
- •Other malignancies actively receiving systemic treatment as per clinician evaluation
研究组 & 干预措施
Mediterranean-type Diet(s)-Arm 1
Diet randomization occurs two weeks prior to the Standard of Care (SOC) diagnostic biopsy. If patient is randomized to Arm 1, they will receive Low Fat (LF) Mediterranean Diet first. The results of the diagnostic biopsy determines how the patient will proceed on the trial. If there is a confirmed Prostate Cancer (PCa) diagnosis AND is a candidate for Active Surveillance (AS) per SOC, then patient will undergo a washout period and cross-over to the Lower Carbohydrate (LC) Mediterranean Diet two weeks prior to the SOC confirmatory biopsy. A long-term follow-up (LTFU) visit will occur 3 months after the second dietary intervention has concluded. If patient does not have PCa or is not placed on AS, then they will only have the first dietary intervention and a LTFU visit 3 months after
干预措施: Lower-Carbohydrate Med-t-Diet (Other)
Mediterranean-type Diet(s)-Arm 1
Diet randomization occurs two weeks prior to the Standard of Care (SOC) diagnostic biopsy. If patient is randomized to Arm 1, they will receive Low Fat (LF) Mediterranean Diet first. The results of the diagnostic biopsy determines how the patient will proceed on the trial. If there is a confirmed Prostate Cancer (PCa) diagnosis AND is a candidate for Active Surveillance (AS) per SOC, then patient will undergo a washout period and cross-over to the Lower Carbohydrate (LC) Mediterranean Diet two weeks prior to the SOC confirmatory biopsy. A long-term follow-up (LTFU) visit will occur 3 months after the second dietary intervention has concluded. If patient does not have PCa or is not placed on AS, then they will only have the first dietary intervention and a LTFU visit 3 months after
干预措施: Low-Fat Med-t-Diet (Other)
Mediterranean-type Diet(s)-Arm 2
Diet randomization occurs two weeks prior to the Standard of Care (SOC) diagnostic biopsy. If patient is randomized to Arm 2, they will receive Lower Carbohydrate (LC) Mediterranean Diet first. The results of the diagnostic biopsy determines how the patient will proceed on the trial. If there is a confirmed Prostate Cancer (PCa) diagnosis AND is a candidate for Active Surveillance (AS) per SOC, then patient will undergo a washout period and cross-over to the Low Fat (LF) Mediterranean Diet two weeks prior to the SOC confirmatory biopsy. A long-term follow-up (LTFU) visit will occur 3 months after the second dietary intervention has concluded. If patient does not have PCa or is not placed on AS, then they will only have the first dietary intervention and a LTFU visit 3 months after.
干预措施: Lower-Carbohydrate Med-t-Diet (Other)
Mediterranean-type Diet(s)-Arm 2
Diet randomization occurs two weeks prior to the Standard of Care (SOC) diagnostic biopsy. If patient is randomized to Arm 2, they will receive Lower Carbohydrate (LC) Mediterranean Diet first. The results of the diagnostic biopsy determines how the patient will proceed on the trial. If there is a confirmed Prostate Cancer (PCa) diagnosis AND is a candidate for Active Surveillance (AS) per SOC, then patient will undergo a washout period and cross-over to the Low Fat (LF) Mediterranean Diet two weeks prior to the SOC confirmatory biopsy. A long-term follow-up (LTFU) visit will occur 3 months after the second dietary intervention has concluded. If patient does not have PCa or is not placed on AS, then they will only have the first dietary intervention and a LTFU visit 3 months after.
干预措施: Low-Fat Med-t-Diet (Other)
结局指标
主要结局
Evaluate the impact of Med-t-Diets on non-malignant prostate tissue metabolism
时间窗: Change from diagnostic biopsy (Week 2) at confirmatory biopsy
Change in non-malignant prostate tissue metabolomics using mass spectrometry to assess differences in ions/metabolites and corresponding metabolic pathways after different dietary interventions expressed as a fold-change. As an exploratory study, metabolomics will be untargeted and as such is not run with a standard curve and does not have a unit of measure.
次要结局
- Changes in energy substrate(s)(Change from baseline at two weeks on diet)
- Changes in blood glucose (mg/dL)(Change from baseline at two weeks on diet)
- Changes in lipid particle number (nmol/L and/or μmol/L)(Change from baseline at two weeks on diet)
- Prostate health changes(Change from baseline at two weeks on diet)
- Safety and tolerability of the diets(Through study completion, an average of 7.5 month)
- Changes in alpha and beta diversity of the gut microbiome(Change from baseline at two weeks on diet)
- Changes in blood metabolomics(Change from baseline at two weeks on diet)
- Changes in ketone levels (mM or mcg/mL)(Change from baseline at two weeks on diet)
- Changes in C-reactive protein (CRP) (mg/L)(Change from baseline at two weeks on diet)
- Changes in lipid particle size (nm)(Change from baseline at two weeks on diet)
- Diet compliance(throughout controlled feeding period(s), two weeks per diet)
- Changes in hemoglobin A1C (HbA1C) (%)(Change from baseline at two weeks on diet)
- Changes in insulin sensitivity [(Homeostatic Model Assessment of Insulin Resistance (HOMA-IR score)](Change from baseline at two weeks on diet)
- Changes in dietary behavior(Through study completion, an average of 7.5 months)