Metabolic Impact of Prospective Controlled Mediterranean Type Diets on Prostate Cancer

NCT ID: NCT05590624

Last Updated: 2025-07-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-03
• Study Completion Date: 2026-06-30

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.

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

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Mediterranean-type Diet(s)-Arm 1

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

Group Type: EXPERIMENTAL

Lower-Carbohydrate Med-t-Diet

Intervention Type: 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

Low-Fat Med-t-Diet

Intervention Type: 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 2

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.

Group Type: EXPERIMENTAL

Lower-Carbohydrate Med-t-Diet

Intervention Type: 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

Low-Fat Med-t-Diet

Intervention Type: 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

Interventions

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

Intervention Type: OTHER

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Case Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christopher Weight, MD

Role: PRINCIPAL_INVESTIGATOR

Center Director, Cleveland Clinic Urologic Oncology

Locations

Case Comprehensive Cancer Center, Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Myra Krnac

Role: CONTACT

krnacm@ccf.org

216-444-1047

Facility Contacts

Myra Krnac

Role: primary

krnacm@ccf.org

216-444-1047

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.

Reference Type: BACKGROUND

PMID: 30664736 (View on 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.

Reference Type: BACKGROUND

PMID: 16094059 (View on PubMed)

Other Identifiers

CASE4822

Identifier Type: -

Identifier Source: org_study_id