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Completed

NCT Number: NCT03084913

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • prostate cancer, BMI 25.0 to 40.0 kg/m2

Exclusion criteria

-

Treatment and study plan

Plant- based, olive oil diet

Other

used as part of daily diet, followed for 8 weeks

Other names: plant-based, olive oil diet

Prostate Cancer Foundation diet

Other

followed for 8 weeks

Primary outcomes

  1. weight loss

    Time frame: 8 weeks

Secondary outcomes

  1. improvement in in fasting blood glucose and insulin

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

The Miriam Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Mar 21, 2017
Registry last updated
Mar 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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