Olive Oil v Prostate Cancer Foundation Diet for Treatment of Prostate Cancer
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Plant- based, olive oil diet
Prostate Cancer Foundation diet
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring dietary treatment
Eligibility Criteria
Inclusion Criteria:
- prostate cancer, BMI 25.0 to 40.0 kg/m2
Exclusion Criteria:
-
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Prostate Cancer Foundation diet
plant- based, olive oil diet
Arm Description
Intervention: 8-weeks of a Prostate Cancer Foundation diet
Intervention: 8 weeks of a plant-based, olive oil diet
Outcomes
Primary Outcome Measures
weight loss
Secondary Outcome Measures
improvement in in fasting blood glucose and insulin
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03084913
Brief Title
Olive Oil v Prostate Cancer Foundation Diet for Treatment of Prostate Cancer
Official Title
Comparing Diets for Weight Loss and Improvement in Cancer Biomarkers in Men With Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
January 1, 2015 (Actual)
Primary Completion Date
November 30, 2016 (Actual)
Study Completion Date
November 30, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Miriam Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
dietary treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Prostate Cancer Foundation diet
Arm Type
Active Comparator
Arm Description
Intervention: 8-weeks of a Prostate Cancer Foundation diet
Arm Title
plant- based, olive oil diet
Arm Type
Experimental
Arm Description
Intervention: 8 weeks of a plant-based, olive oil diet
Intervention Type
Other
Intervention Name(s)
Plant- based, olive oil diet
Other Intervention Name(s)
plant-based, olive oil diet
Intervention Description
used as part of daily diet, followed for 8 weeks
Intervention Type
Other
Intervention Name(s)
Prostate Cancer Foundation diet
Intervention Description
followed for 8 weeks
Primary Outcome Measure Information:
Title
weight loss
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
improvement in in fasting blood glucose and insulin
Time Frame
8 weeks
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
Prostate cancer
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
prostate cancer, BMI 25.0 to 40.0 kg/m2
Exclusion Criteria:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary M Flynn, PhD, RD
Organizational Affiliation
Research Dietitian
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Olive Oil v Prostate Cancer Foundation Diet for Treatment of Prostate Cancer
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