Olive Oil v Prostate Cancer Foundation Diet for Treatment of Prostate Cancer

Study Overview
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Brief Summary
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This study compared a plant-based, olive oil diet to the diet recommended by the Prostate Cancer Foundation for weight loss and improvement in some laboratory biomarkers.

Detailed Description
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Dietary treatment of overweight/ obese men with prostate cancer has not been well studied. As men with prostate cancer who are overweight/ obese are at an increase risk of recurrence, metastasis and mortality, elucidating a diet that will both improve biomarkers for prostate cancer and lead to long-term weight management could improve survivorship. The primary objective of this proposal is to compare a plant-based, olive oil (PBOO) diet to a conventional diet for weight loss and improvement in metabolic biomarkers (specifically fasting insulin, glucose, and triglycerides) for overweight/ obese men diagnosed with prostate cancer on surveillance or who have had an asymptomatic biochemical failure after primary therapy. The secondary objective is to determine which diet will be more acceptable for long term use. Participants will consume for 8 weeks each a conventional diet for treating prostate cancer and a PBOO diet for weight loss and improvement in biomarkers with random assignment to the diet order. They will choose one of the diets for 6 months of follow-up. Blood samples and body weight will be obtained pre- and post diet and after 6 months of follow-up and compared between the diets. Based on earlier work by colleagues of the PI, it is anticipated that the PBOO diet will result in better weight loss and biomarkers and will be more acceptable for long-term weight management. This protocol has the potential to elucidate a diet that will improve the body weight and survival of men with prostate cancer.

Official Title
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Comparing Diets for Weight Loss and Improvement in Cancer Biomarkers in Men With Prostate Cancer

Conditions
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Prostate Cancer

Intervention / Treatment
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* Other: Plant- based, olive oil diet
* Other: Prostate Cancer Foundation diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: prostate cancer, BMI 25.0 to 40.0 kg/m2 Exclusion Criteria: -
Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Prostate Cancer Foundation diet<br>Intervention: 8-weeks of a Prostate Cancer Foundation diet | Other: Plant- based, olive oil diet<br>* used as part of daily diet, followed for 8 weeks<br>* Other names: plant-based, olive oil diet;Other: Prostate Cancer Foundation diet<br>* followed for 8 weeks<br>|
| Experimental: plant- based, olive oil diet<br>Intervention: 8 weeks of a plant-based, olive oil diet | Other: Plant- based, olive oil diet<br>* used as part of daily diet, followed for 8 weeks<br>* Other names: plant-based, olive oil diet;Other: Prostate Cancer Foundation diet<br>* followed for 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight loss |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improvement in in fasting blood glucose and insulin |  | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dietary treatment