Back to search results

Dietary Impact on Prostate Cancer Metabolism Study

This study is looking into how different Mediterranean-type diets affect the body's processes (metabolism) in men with suspected prostate cancer. Researchers want to see if a Lower-Carbohydrate Med-t-Diet or a Low-Fat Med-t-Diet can change prostate tissue metabolism. These diets focus on lean protein, healthy fats, fiber-rich carbohydrates, nuts, and seeds, while limiting refined sugars and certain oils. The study aims to enroll 30 men aged 18 or older who have a high suspicion of prostate cancer and are considering active surveillance. The main goal is to see how these diets impact non-cancerous prostate tissue at the time of a follow-up biopsy.

Study design
This is an interventional study planning to enroll 30 men. It compares two different Mediterranean-type diets.
What's involved
You would follow a specific diet (either Lower-Carbohydrate Med-t-Diet or Low-Fat Med-t-Diet) between your diagnostic biopsy and a confirmatory biopsy.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome is measured at the time of a confirmatory biopsy, which is after the diagnostic biopsy.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05590624

Metabolic Impact of Prospective Controlled Mediterranean Type Diets on Prostate Cancer

Recruiting
NAAges 18+Interventional
Case Comprehensive Cancer Center
~30 participants
Updated 2026-02-19 on ClinicalTrials.gov
What's tested:Lower-Carbohydrate Med-t-DietLow-Fat Med-t-Diet

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Evaluate the impact of Med-t-Diets on non-malignant prostate tissue metabolism
Measured over Change from diagnostic biopsy (Week 2) at confirmatory biopsy

Conditions

Prostate Cancer

Explore related trials

Prostate Carcinoma

Where it's being run

1 sites across 1 states
Ohio1

Study leadership

  • Christopher Weight, MD · PRINCIPAL_INVESTIGATOR · Center Director, Cleveland Clinic Urologic Oncology

Who to contact

Myra Krnac
[email protected]
216-444-1047
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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

What this trial measures

  • Evaluate the impact of Med-t-Diets on non-malignant prostate tissue metabolismChange from diagnostic biopsy (Week 2) at confirmatory biopsy

    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.