Metabolic Impact of Prospective Controlled Mediterranean Type Diets on Prostate Cancer

NCT05590624 | Recruiting

• 1 other identifier: CASE4822
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

Mediterranean-type Diets

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• Changes in blood metabolomics

  Change from baseline at two weeks on diet

• Changes in energy substrate(s)

  Change from baseline at two weeks on diet

• Changes in blood glucose (mg/dL)

  Change from baseline at two weeks on diet

• Changes in ketone levels (mM or mcg/mL)

  Change from baseline at two weeks on diet

• Changes in hemoglobin A1C (HbA1C) (%)

  Change from baseline at two weeks on diet

Study Arms (2)

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

Other: Lower-Carbohydrate Med-t-Diet; Other: Low-Fat Med-t-Diet

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.

Other: Lower-Carbohydrate Med-t-Diet; Other: Low-Fat Med-t-Diet

Interventions

Lower-Carbohydrate Med-t-Diet OTHER

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

Mediterranean-type Diet(s)-Arm 1; Mediterranean-type Diet(s)-Arm 2

Low-Fat Med-t-Diet OTHER

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

Mediterranean-type Diet(s)-Arm 1; Mediterranean-type Diet(s)-Arm 2

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (1)

Case Comprehensive Cancer Center, Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

RECRUITING

Related 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.

  PMID: 30664736 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.

  PMID: 16094059 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Christopher Weight, MD

  Center Director, Cleveland Clinic Urologic Oncology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Myra Krnac

CONTACT

216-444-1047; krnacm@ccf.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: September 23, 2022
• First Posted: October 21, 2022
• Study Start: September 3, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 19, 2026

Record last verified: 2026-02

Locations

US (1)