Metabolic Impact of Prospective Controlled Mediterranean Type Diets on Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05590624
• Other study ID #: CASE4822
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: February 2024
• Source: Case Comprehensive Cancer Center
• Contact: Dianna Sendrey, RN, BSN
• Phone: (216) 444-0486
• Email: sendred2[@]ccf.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 31, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Other:
• 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
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the impact of Med-t-Diets on non-malignant prostate tissue metabolism	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.	Change from diagnostic biopsy (Week 2) at confirmatory biopsy
Secondary	Changes in blood metabolomics	Change in blood 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	Change from baseline at two weeks on diet
Secondary	Changes in energy substrate(s)	Change measured by respiratory exchange ratio (VCO2/VO2) difference between baseline and at two weeks on diet	Change from baseline at two weeks on diet
Secondary	Changes in blood glucose (mg/dL)	Change as measured by the difference between blood glucose levels at baseline and at week two on diet	Change from baseline at two weeks on diet
Secondary	Changes in ketone levels (mM or mcg/mL)	Change measured by the difference between ketone levels between baseline and at two weeks on diet	Change from baseline at two weeks on diet
Secondary	Changes in hemoglobin A1C (HbA1C) (%)	Change measured by the difference between A1C levels at baseline and at 2 weeks on diet	Change from baseline at two weeks on diet
Secondary	Changes in C-reactive protein (CRP) (mg/L)	Change measured by the difference between CRP levels at baseline and at 2 weeks on diet	Change from baseline at two weeks on diet
Secondary	Changes in lipid particle size (nm)	Change measured by the difference in lipid particle size at baseline and at 2 weeks on diet using Nuclear Magnetic Resonance (NMR).	Change from baseline at two weeks on diet
Secondary	Changes in lipid particle number (nmol/L and/or µmol/L)	Change measured by the difference in lipid particle number at baseline and at 2 weeks on diet using Nuclear Magnetic Resonance (NMR)	Change from baseline at two weeks on diet
Secondary	Changes in insulin sensitivity [(Homeostatic Model Assessment of Insulin Resistance (HOMA-IR score)]	Change as measured by the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) score using fasting insulin and glucose from longitudinal blood specimens at baseline and at two weeks on diet. The HOMA-IR test tests how resistant a participant is to insulin. A score of less than 1 indicates that a participant is insulin-sensitive, a score greater than 1.9 indicates some insulin resistance, and a score greater than 2.9 indicates significant insulin resistance.	Change from baseline at two weeks on diet
Secondary	Prostate health changes	As measured by changes in the Prostate Health Index	Change from baseline at two weeks on diet
Secondary	Safety and tolerability of the diets	Safety and tolerability measured by the number of adverse events and by the gastric tolerance questionnaire	Through study completion, an average of 7.5 month
Secondary	Changes in alpha and beta diversity of the gut microbiome	Changes measured by Shannon or Simpson diversity index (alpha diversity) and pairwise Bray-Curtis metric values (beta diversity)	Change from baseline at two weeks on diet
Secondary	Changes in dietary behavior	Behavioral changes measured by validated 24 hour dietary recalls collected by trained dietetics personnel on 2 week days and 1 weekend to capture specific dietary information	Through study completion, an average of 7.5 months
Secondary	Diet compliance	Compliance measured by >90% of provided calories consumed	throughout controlled feeding period(s), two weeks per diet