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RecruitingInterventional

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

NCT ID: NCT05590624Sponsor: Case Comprehensive Cancer CenterLast updated: 2026-02-19

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

Sex: MaleAge: 18 Years and olderHealthy volunteers: No
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

Study locations (1)

Case Comprehensive Cancer Center, Cleveland Clinic Foundation

Cleveland, Ohio, 44195

Recruiting
Myra Krnac · Contact

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)
Metabolic Impact of Prospective Controlled Mediterranean Type Diets on Prostate Cancer | Cancerify