Mediterranean Diets for Prostate Cancer

Overseen By Nima Sharifi, MD

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: University of Miami

Must not be taking: Supplements, Vitamins, Minerals, others

Disqualifiers: Diabetes, Gastrointestinal conditions, Immunosuppressed, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

20 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are taking supplements, vitamins, or minerals that could interfere with the study's diet, you may need to stop those. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the Mediterranean Diet treatment for prostate cancer?

Research suggests that following a Mediterranean diet may help reduce DNA damage in men with prostate cancer, which is beneficial because DNA damage can lead to cancer progression. Additionally, the diet's high antioxidant content, including nutrients like folate and vitamin C, may contribute to its protective effects. ^{1 2 3 4 5}

Is the Mediterranean diet safe for humans?

The Mediterranean diet is generally considered safe for humans and may offer protective benefits against chronic diseases. Studies suggest it can reduce DNA damage and has anti-inflammatory properties, which are beneficial for overall health. ^{1 4 5 6 7}

How does the Mediterranean diet treatment differ from other prostate cancer treatments?

The Mediterranean diet treatment for prostate cancer is unique because it focuses on dietary changes rather than medication, emphasizing anti-inflammatory and chemopreventive properties through foods like fish and omega-3 fatty acids, which may help slow cancer progression. ^{2 4 7 8 9}

What is the purpose of this trial?

The study aims to investigate whether following a controlled Mediterranean-style diet prior to robotic-assisted radical prostatectomy surgery in patients diagnosed with prostate cancer affects fasting insulin levels and other values that can be measured in blood and tissue samples from surgery.

Research Team

Nima Sharifi, MD

Principal Investigator

University of Miami

Eligibility Criteria

This trial is for men diagnosed with prostate cancer who are scheduled to undergo robotic-assisted radical prostatectomy. Participants should be willing to follow a specific Mediterranean-style diet before surgery.

Inclusion Criteria

BMI between 18.5 and 40

I can read, write, speak, and understand English or Spanish.

Ability to provide informed consent

Exclusion Criteria

I have had radiation therapy to my pelvic area before.

I have a gastrointestinal condition like colitis or IBS, as diagnosed by my doctor.

Patients that are immunosuppressed (transplant history, on immunosuppression, etc.) as per clinician discretion

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Diet Intervention

Participants follow a controlled Mediterranean-style diet prior to surgery

2 weeks

1 visit (in-person) for diet instruction

Surgery

Participants undergo robotic-assisted radical prostatectomy surgery

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in fasting insulin and other metabolic markers

2 weeks

1 visit (in-person) for follow-up assessments

Treatment Details

Interventions

• Controlled, Varying, Mediterranean Diets

Trial Overview The study is testing the effects of two types of Mediterranean diets—one low in fat and the other lower in carbohydrates—on fasting insulin levels and other measurable values from blood and tissue samples taken during prostate cancer surgery.

Participant Groups

Group I: Lower Carbohydrate Mediterranean Diet Group Experimental Treatment 1 Intervention

Participants in this group will receive a lower carbohydrate Mediterranean diet for 2 weeks.

Group II: Low Fat Diet Group Experimental Treatment 1 Intervention

Participants in this group will receive a low fat Mediterranean diet for 2 weeks.

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

Findings from Research

In a study of 564 men with localized prostate cancer under active surveillance, following specific dietary patterns like the Healthy Eating Index (HEI)-2015, Mediterranean Diet (aMED), or DASH did not significantly reduce the risk of disease progression as measured by Gleason score increases over a median follow-up of 7.8 years.

Despite not showing a direct impact on prostate cancer progression, these dietary patterns are still beneficial for overall health and may help prevent other chronic diseases, making them a good choice for men with prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary Patterns and Risk of Gleason Grade Progression among Men on Active Surveillance for Prostate Cancer: Results from the Canary Prostate Active Surveillance Study. Schenk, JM., Liu, M., Neuhouser, ML., et al.[2023]

In a study of 410 men with localized prostate cancer on active surveillance, higher adherence to the Mediterranean diet was linked to a lower risk of progression in Gleason scores, suggesting potential benefits for cancer management.

The protective effect of the Mediterranean diet was particularly strong in non-White men and those without diabetes, indicating that dietary factors may play a significant role in cancer progression among different demographic groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence to the Mediterranean diet and grade group progression in localized prostate cancer: An active surveillance cohort. Gregg, JR., Zhang, X., Chapin, BF., et al.[2023]

Selenium shows the most promise among bioactive constituents of the Mediterranean diet for reducing prostate cancer risk, while vitamins C and E have mixed evidence regarding their effectiveness.

Lycopene and resveratrol have been shown to inhibit prostate cancer cell proliferation and development, suggesting that the phytochemicals in the Mediterranean diet may play a protective role against prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bioactive compounds of the Mediterranean diet and prostate cancer. López-Guarnido, O., Urquiza-Salvat, N., Saiz, M., et al.[2019]

In a study of 47,867 men followed from 1986 to 2010, adherence to the traditional Mediterranean diet (Med-Diet) was not linked to a reduced risk of advanced or lethal prostate cancer (PCa).

However, among men diagnosed with nonmetastatic PCa, greater adherence to the Med-Diet after diagnosis was associated with a 22% lower risk of overall mortality, suggesting potential benefits for survival rather than disease progression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mediterranean diet and prostate cancer risk and mortality in the Health Professionals Follow-up Study. Kenfield, SA., DuPre, N., Richman, EL., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Dietary Patterns and Risk of Gleason Grade Progression among Men on Active Surveillance for Prostate Cancer: Results from the Canary Prostate Active Surveillance Study. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Index-based dietary patterns and the risk of prostate cancer in the NIH-AARP diet and health study. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Mediterranean Dietary Pattern is Associated with Low Risk of Aggressive Prostate Cancer: MCC-Spain Study. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Adherence to the Mediterranean diet and grade group progression in localized prostate cancer: An active surveillance cohort. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

A pilot study to investigate if New Zealand men with prostate cancer benefit from a Mediterranean-style diet. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Dietary patterns and prostate cancer risk: report from the population based ULSAM cohort study of Swedish men. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Bioactive compounds of the Mediterranean diet and prostate cancer. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Mediterranean Diet Score and prostate cancer risk in a Swedish population-based case-control study. [2021]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Mediterranean diet and prostate cancer risk and mortality in the Health Professionals Follow-up Study. [2021]