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Official title Metabolic Impact of Prospective Controlled Mediterranean Type Diets on Prostate Cancer
ClinicalTrials.gov ID: NCT05590624
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join 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
You likely can't join if
- Currently consuming a Mediterranean, lower carbohydrate, ketogenic, vegan, vegetarian, high fiber diet (14g fiber \> per 1,000 Calories) and/or any...
- 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
See the full eligibility 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Cleveland, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cleveland, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.