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

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ClinicalTrials.gov Identifier: NCT03084913
Recruitment Status : Completed
First Posted : March 21, 2017
Last Update Posted : March 21, 2017
Sponsor:
Information provided by (Responsible Party):
Mary Flynn, The Miriam Hospital

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Other: Plant- based, olive oil diet Other: Prostate Cancer Foundation diet Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparing Diets for Weight Loss and Improvement in Cancer Biomarkers in Men With Prostate Cancer
Actual Study Start Date : January 1, 2015
Actual Primary Completion Date : November 30, 2016
Actual Study Completion Date : November 30, 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Olive oil

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 Name: 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 Name: plant-based, olive oil diet

Other: Prostate Cancer Foundation diet
followed for 8 weeks




Primary Outcome Measures :
  1. weight loss [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. improvement in in fasting blood glucose and insulin [ Time Frame: 8 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Prostate cancer
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • prostate cancer, BMI 25.0 to 40.0 kg/m2

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03084913


Sponsors and Collaborators
The Miriam Hospital
Investigators
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Principal Investigator: Mary M Flynn, PhD, RD Research Dietitian

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Responsible Party: Mary Flynn, Research dietitian, Associate professor of Medicine, The Miriam Hospital
ClinicalTrials.gov Identifier: NCT03084913     History of Changes
Other Study ID Numbers: 2134-14
First Posted: March 21, 2017    Key Record Dates
Last Update Posted: March 21, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mary Flynn, The Miriam Hospital:
dietary treatment

Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases