Actively Recruiting
Metabolic Impact of Prospective Controlled Mediterranean Type Diets on Prostate Cancer
Led by Case Comprehensive Cancer Center · Updated on 2026-02-19
30
Participants Needed
1
Research Sites
117 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Metabolic Impact of Prospective Controlled Mediterranean Type Diets on Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male aged 18 years or older
- High suspicion of prostate cancer by urologist evaluation
- Body mass index (BMI) greater than 18.5
- No prior diagnosis or hormonal treatment for prostate cancer
- Ability to read, write, speak, and understand English
- Ability to provide informed consent
- Candidate for and chooses active surveillance if biopsy confirms prostate cancer
- Willing to consume the study-provided diets
- Adequate organ and marrow function including specified blood counts and liver and kidney function tests
You will not qualify if you...
- Currently following Mediterranean, lower carbohydrate, ketogenic, vegan, vegetarian, or high fiber diets, or taking supplements that interfere with study diets
- Previous intolerance to fiber-rich diets
- Diagnosed colitis, irritable bowel syndrome, or other gastrointestinal conditions
- Unwilling to undergo transperineal prostate biopsies
- Food allergies or major dietary restrictions
- Receiving active treatment for Type I or II diabetes
- Antibiotic use within 30 days before consent
- Recent weight loss of 5% or more in last 30 days
- History of weight loss surgery
- Any medical contraindications determined by investigators
- High risk defined by PSA 20 or above and/or certain lesion types
- History of diabetic ketoacidosis or gout
- Immunosuppression due to transplant or medications
- Recent device implant or joint requiring antibiotics
- Prior prostate biopsy infection
- Uncontrolled high blood pressure (above 140/80)
- Gallbladder removal or planned removal
- Other active malignancies receiving systemic treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Case Comprehensive Cancer Center, Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Actively Recruiting
Research Team
M
Myra Krnac
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
OTHER
Number of Arms
2
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