Clinical trial NCT05590624: Metabolic Impact of Prospective Controlled Mediterranean Type Diets on Prostate Cancer
Official title: Elucidating the Metabolic Impact of Isocaloric, Controlled, Mediterranean-Type Diets in Treatment-Naïve Men With Prostate Cancer on Active Surveillance (DINE Study)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
Keywords: Mediterranean-type Diets
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2022-10-21
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Patients will be randomized to one of two arms which only differ in the order they will receive the two dietary interventions \[Lower Carbohydrate (LC) and Low Fat (LF)\]. All dietary interventions are on a Mediterranean foundation and are opposite in carbohydrate and fat content.

Arm 1 \[n=15 with confirmed PCa diagnosis and candidate for Active Surveillance (AS) per Standard of Care (SOC)\]: Dietary Intervention #1=Low Fat (LF) Mediterranean. Dietary Intervention #2=Lower Carbohydrate (LC) Mediterranean

Arm 2 (n=15 with confirmed PCa diagnosis and candidate for AS per SOC): Dietary Intervention #1=LC Mediterranean. Dietary Intervention #2=LF Mediterranean
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Evaluate the impact of Med-t-Diets on non-malignant prostate tissue metabolism
timeFrame: Change from diagnostic biopsy (Week 2) at confirmatory biopsy
Secondary outcomes:
measure: Changes in blood metabolomics
timeFrame: Change from baseline at two weeks on diet
measure: Changes in energy substrate(s)
timeFrame: Change from baseline at two weeks on diet
measure: Changes in blood glucose (mg/dL)
timeFrame: Change from baseline at two weeks on diet
measure: Changes in ketone levels (mM or mcg/mL)
timeFrame: Change from baseline at two weeks on diet
measure: Changes in hemoglobin A1C (HbA1C) (%)
timeFrame: Change from baseline at two weeks on diet
measure: Changes in C-reactive protein (CRP) (mg/L)
timeFrame: Change from baseline at two weeks on diet
measure: Changes in lipid particle size (nm)
timeFrame: Change from baseline at two weeks on diet
measure: Changes in lipid particle number (nmol/L and/or μmol/L)
timeFrame: Change from baseline at two weeks on diet
measure: Changes in insulin sensitivity [(Homeostatic Model Assessment of Insulin Resistance (HOMA-IR score)]
timeFrame: Change from baseline at two weeks on diet
measure: Prostate health changes
timeFrame: Change from baseline at two weeks on diet
measure: Safety and tolerability of the diets
timeFrame: Through study completion, an average of 7.5 month
measure: Changes in alpha and beta diversity of the gut microbiome
timeFrame: Change from baseline at two weeks on diet
measure: Changes in dietary behavior
timeFrame: Through study completion, an average of 7.5 months
measure: Diet compliance
timeFrame: throughout controlled feeding period(s), two weeks per diet
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Case Comprehensive Cancer Center, Cleveland Clinic Foundation
state: Ohio
Study officials:
affiliation: Center Director, Cleveland Clinic Urologic Oncology
name: Christopher Weight, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. 2019 Sep;22(3):428-437. doi: 10.1038/s41391-019-0126-5. Epub 2019 Jan 21.
citation: 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.