RECRUITING

Metabolic Impact of Prospective Controlled Mediterranean Type Diets on Prostate Cancer

Conditions

Prostate Cancer Mediterranean-type Diets

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Elucidating the Metabolic Impact of Isocaloric, Controlled, Mediterranean-Type Diets in Treatment-Naïve Men With Prostate Cancer on Active Surveillance (DINE Study)

Quick Facts

Study Start:2024-09-03

Study Completion:2025-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05590624

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Myra Krnac

CONTACT

216-444-1047

krnacm@ccf.org

Principal Investigator

Christopher Weight, MD

PRINCIPAL_INVESTIGATOR

Center Director, Cleveland Clinic Urologic Oncology

Study Locations (Sites)

Case Comprehensive Cancer Center, Cleveland Clinic Foundation

Cleveland, Ohio, 44195

United States

Collaborators and Investigators

Sponsor: Case Comprehensive Cancer Center

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-03

Study Completion Date2025-12-31

Study Record Updates

Study Start Date2024-09-03

Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

Mediterranean-type Diets

Additional Relevant MeSH Terms

Prostate Cancer