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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.
Primary Objective
-Evaluate the impact of Mediterranean diets (Med-t-Diets) on non-malignant prostate tissue metabolism
Secondary Objectives
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mediterranean-type Diet(s)-Arm 1 | Experimental | 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 |
|
| Mediterranean-type Diet(s)-Arm 2 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lower-Carbohydrate Med-t-Diet | Other | Diet will focus on including:
Diet will focus on limiting:
Diet Composition: 45% fats, 35% carbs, 20% protein |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Myra Krnac | Contact | 216-444-1047 | krnacm@ccf.org |
| Name | Affiliation | Role |
|---|---|---|
| Christopher Weight, MD | Center Director, Cleveland Clinic Urologic Oncology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Case Comprehensive Cancer Center, Cleveland Clinic Foundation | Recruiting | Cleveland | Ohio | 44195 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30664736 | Background | 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. | |
| 16094059 |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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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
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|
| Low-Fat Med-t-Diet | Other | Diet will focus on including:
Diet will focus on limiting:
Diet Composition: 70% carbs, 20% protein, 10% fat |
|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Prostate health changes | As measured by changes in the Prostate Health Index | Change from baseline at two weeks on diet |
| 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 |
| 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 |
| 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 |
| Diet compliance | Compliance measured by >90% of provided calories consumed | throughout controlled feeding period(s), two weeks per diet |
| Background |
| 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. |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |