Metabolic Impact of Prospective Controlled Mediterranean Type Diets on Prostate Cancer

Официальное название

Elucidating the Metabolic Impact of Isocaloric, Controlled, Mediterranean-Type Diets in Treatment-Naïve Men With Prostate Cancer on Active Surveillance (DINE Study)

Обзор

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.

Подробное описание

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

Вмешательства

• Другое Lower-Carbohydrate Med-t-Diet
  Diet will focus on including: * Lean protein sources * High-quality fat * High-quality carbohydrate sources that are rich in fiber * Nuts and seeds Diet will focus on limiting: * Refined sugars * High glycemic carbohydrates * Seed oils that may cause inflammation Diet Composition: 45% fats, 35% carbs, 20% protein
• Другое Low-Fat Med-t-Diet
  Diet will focus on including: * Lean protein sources * High-quality fat * High-quality carbohydrate sources that are rich in fiber * Nuts and seeds Diet will focus on limiting: * Refined sugars * High glycemic carbohydrates * Seed oils that may cause inflammation Diet Composition: 70% carbs, 20% protein, 10% fat

Первичные конечные точки

• Evaluate the impact of Med-t-Diets on non-malignant prostate tissue metabolism [Срок оценки: Change from diagnostic biopsy (Week 2) at confirmatory biopsy]

Вторичные конечные точки (12)

• Changes in blood metabolomics [Срок оценки: Change from baseline at two weeks on diet]
• Changes in energy substrate(s) [Срок оценки: Change from baseline at two weeks on diet]
• Changes in blood glucose (mg/dL) [Срок оценки: Change from baseline at two weeks on diet]
• Changes in ketone levels (mM or mcg/mL) [Срок оценки: Change from baseline at two weeks on diet]
• Changes in hemoglobin A1C (HbA1C) (%) [Срок оценки: Change from baseline at two weeks on diet]
• Changes in C-reactive protein (CRP) (mg/L) [Срок оценки: Change from baseline at two weeks on diet]
• Changes in lipid particle size (nm) [Срок оценки: Change from baseline at two weeks on diet]
• Changes in lipid particle number (nmol/L and/or μmol/L) [Срок оценки: Change from baseline at two weeks on diet]
• Changes in insulin sensitivity [(Homeostatic Model Assessment of Insulin Resistance (HOMA-IR score)] [Срок оценки: Change from baseline at two weeks on diet]
• Prostate health changes [Срок оценки: Change from baseline at two weeks on diet]
• Safety and tolerability of the diets [Срок оценки: Through study completion, an average of 7.5 month]
• Changes in alpha and beta diversity of the gut microbiome [Срок оценки: Change from baseline at two weeks on diet]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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
• Gout
• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Другое

Центры проведения

США · 1 центр

• Case Comprehensive Cancer Center, Cleveland Clinic Foundation — Cleveland

Публикации

• Freedland SJ, Howard L, Allen J, Smith J, Stout J, Aronson W, Inman BA, Armstrong AJ, George D, Westman E, Lin PH. A lifestyle intervention of weight loss via a low-carbohydrate diet plus walking to reduce metabolic disturbances caused by androgen deprivation therapy among prostate cancer patients: carbohydrate and prostate study 1 (CAPS1) randomized controlled trial. Prostate Cancer Prostatic Dis PMID 30664736
• Ornish D, Weidner G, Fair WR, Marlin R, Pettengill EB, Raisin CJ, Dunn-Emke S, Crutchfield L, Jacobs FN, Barnard RJ, Aronson WJ, McCormac P, McKnight DJ, Fein JD, Dnistrian AM, Weinstein J, Ngo TH, Mendell NR, Carroll PR. Intensive lifestyle changes may affect the progression of prostate cancer. J Urol. 2005 Sep;174(3):1065-9; discussion 1069-70. doi: 10.1097/01.ju.0000169487.49018.73. PMID 16094059

Идентификаторы

NCT: NCT05590624 · CASE4822

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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