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

March 20, 2017 updated by: Mary Flynn, The Miriam Hospital

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

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.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • prostate cancer, BMI 25.0 to 40.0 kg/m2

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Prostate Cancer Foundation diet
Intervention: 8-weeks of a Prostate Cancer Foundation diet
Other: Plant- based, olive oil diet
used as part of daily diet, followed for 8 weeks
Other Names:
  • plant-based, olive oil diet
Other: Prostate Cancer Foundation diet
followed for 8 weeks
Experimental: plant- based, olive oil diet
Intervention: 8 weeks of a plant-based, olive oil diet
Other: Plant- based, olive oil diet
used as part of daily diet, followed for 8 weeks
Other Names:
  • plant-based, olive oil diet
Other: Prostate Cancer Foundation diet
followed for 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
weight loss
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
improvement in in fasting blood glucose and insulin
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Miriam Hospital

Investigators

  • Principal Investigator: Mary M Flynn, PhD, RD, Research Dietitian

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 Major Dates

Study Start (Actual)

January 1, 2015

Primary Completion (Actual)

November 30, 2016

Study Completion (Actual)

November 30, 2016

Study Registration Dates

First Submitted

March 9, 2017

First Submitted That Met QC Criteria

March 20, 2017

First Posted (Actual)

March 21, 2017

Study Record Updates

Last Update Posted (Actual)

March 21, 2017

Last Update Submitted That Met QC Criteria

March 20, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2134-14

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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