Elucidating the Metabolic Impact of Isocaloric, Controlled, Mediterranean-Type Diets in Treatment-Naïve Men With Prostate Cancer on Active Surveillance (DINE Study)
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
Arms & interventions
- OtherLower-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
- OtherLow-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
Outcome measures
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.
Time frame: Change from diagnostic biopsy (Week 2) at confirmatory biopsy
Secondary
Changes in blood metabolomics
Time frame: Change from baseline at two weeks on diet
Changes in energy substrate(s)
Time frame: Change from baseline at two weeks on diet
Changes in blood glucose (mg/dL)
Time frame: Change from baseline at two weeks on diet
Changes in ketone levels (mM or mcg/mL)
Time frame: Change from baseline at two weeks on diet
Changes in hemoglobin A1C (HbA1C) (%)
Time frame: Change from baseline at two weeks on diet
Changes in C-reactive protein (CRP) (mg/L)
Time frame: Change from baseline at two weeks on diet
Changes in lipid particle size (nm)
Time frame: Change from baseline at two weeks on diet
Changes in lipid particle number (nmol/L and/or μmol/L)
Time frame: Change from baseline at two weeks on diet
Changes in insulin sensitivity [(Homeostatic Model Assessment of Insulin Resistance (HOMA-IR score)]
Time frame: Change from baseline at two weeks on diet
Prostate health changes
Time frame: Change from baseline at two weeks on diet
Safety and tolerability of the diets
Time frame: Through study completion, an average of 7.5 month
Changes in alpha and beta diversity of the gut microbiome
Time frame: Change from baseline at two weeks on diet
Changes in dietary behavior
Time frame: Through study completion, an average of 7.5 months
Diet compliance
Time frame: throughout controlled feeding period(s), two weeks per diet
Eligibility criteria
Study locations (1)
Case Comprehensive Cancer Center, Cleveland Clinic Foundation
Cleveland, Ohio, 44195
References
- 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.(PubMed)
- 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.(PubMed)