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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different Mediterranean-style diets affect prostate cancer patients before surgery. Participants will follow either a low-fat or lower-carbohydrate Mediterranean diet for two weeks. The main focus is to determine if these diets change levels of fasting insulin and other markers in blood and tissue samples. Men with prostate cancer who are scheduled for surgery and not already on a special diet might be suitable candidates for this study. As an unphased trial, this study offers a unique opportunity to contribute to understanding dietary impacts on prostate cancer.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Mediterranean diets, whether low-fat or low-carb, are generally safe for people. These diets, which include more fruits, vegetables, beans, grains, and fish, can help lower the risk of prostate cancer progression.

No major harmful effects have been reported from following these Mediterranean-style diets. They are often linked to health benefits, such as improved heart health and reduced inflammation. Some studies even suggest these diets might slow prostate cancer growth.

While more evidence supports the low-fat diet, further research is needed to understand how the low-carb diet affects prostate cancer. Overall, these diets are safe and well-tolerated by most people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these Mediterranean diet approaches for prostate cancer because they focus on dietary changes rather than traditional medical treatments like surgery, radiation, or hormone therapy. The low-fat Mediterranean diet arm emphasizes reducing unhealthy fats, which might help manage cancer growth by lowering inflammation. The lower carbohydrate Mediterranean diet arm potentially impacts cancer cell metabolism by reducing sugar intake, which can starve cancer cells of energy. These dietary strategies offer a non-invasive way to potentially support prostate cancer management, making them appealing options to explore.

What evidence suggests that this trial's Mediterranean diets could be effective for prostate cancer?

Research shows that following a Mediterranean diet might help reduce the risk of prostate cancer worsening. This diet includes plenty of fruits, vegetables, beans, grains, and fish. Studies have found that people who eat this way have a lower chance of their cancer advancing. In this trial, participants in the Low Fat Diet Group will receive a low-fat version of the Mediterranean diet, which is linked to fewer aggressive prostate cancer tumors and a lower risk of dying from cancer.

Participants in the Lower Carbohydrate Mediterranean Diet Group will receive a Mediterranean diet with fewer carbohydrates. Evidence for this version is mixed; some studies suggest it might slow cancer progression, while others find no clear advantage over other diets. Overall, both types of the Mediterranean diet show promise, but more research is needed to confirm their effectiveness for prostate cancer. ^{2 4 6 7 8}

Who Is on the Research Team?

Nima Sharifi, MD

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

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.

Food allergies or other major dietary restrictions

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

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Mediterranean diet may decrease risk of prostate cancer ...

Men with a diet that contained more fruits, vegetables, legumes, cereals and fish had a reduced risk of their prostate cancer growing or advancing.

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5573712/

The Mediterranean Diet Reduces the Risk and Mortality of the ...

Specifically, a two-point increment in the Mediterranean-diet score corresponded to 24% reduction in mortality for cancer (HR 0.76; 95% CI 0.59– ...

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europeanurology.com

europeanurology.com/article/S0302-2838(25)00433-6/fulltext

Dietary Patterns in Prostate Cancer Prevention and ...

Among patients with PC, Mediterranean, plant-based, and low-inflammatory diets were more consistently linked to lower risk of progression and PC ...

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ajmc.com

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Mediterranean Diet Might Benefit Low-Risk Prostate ...

“The Mediterranean diet consistently has been linked to lower risk of cancer, cardiovascular disease, and mortality,” senior author Carrie ...

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sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0022534717773855

Mediterranean Dietary Pattern is Associated with Low Risk ...

The Mediterranean diet, which is rich not only in fruits and vegetables but also in fish, legumes and olive oil, could help prevent aggressive PC tumors.

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4157361/

Mediterranean Diet and Prostate Cancer Risk and Mortality ...

Our results suggest no statistically significant association between the Med-Diet prior to diagnosis and incidence of advanced, lethal, or fatal ...

7.

cancer.gov

cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2023-06637

Metabolic Impact of Lower Carbohydrate and Low Fat ...

This clinical trial studies the metabolic impact of lower carbohydrate (LC) and low fat (LF) Mediterranean-type diets (Med-t-Diets) in men with prostate cancer

8.

journals.lww.com

journals.lww.com/md-journal/fulltext/2019/07050/mediterranean_dietary_pattern_and_the_risk_of.103.aspx

Mediterranean dietary pattern and the risk of prostate cancer

Our meta-analysis of 10 eligible epidemiological studies provides evidence that Mediterranean Diet is not related with the risk of total, advanced, localized, ...