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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
The Miriam Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring dietary treatment

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

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

    First Posted
    March 9, 2017
    Last Updated
    March 20, 2017
    Sponsor
    The Miriam Hospital
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    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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