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

NCT ID: NCT03084913

Last Updated: 2017-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-01
• Study Completion Date: 2016-11-30

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Prostate Cancer Foundation diet

Intervention: 8-weeks of a Prostate Cancer Foundation diet

Group Type: ACTIVE_COMPARATOR

Plant- based, olive oil diet

Intervention Type: OTHER

used as part of daily diet, followed for 8 weeks

Prostate Cancer Foundation diet

Intervention Type: OTHER

followed for 8 weeks

plant- based, olive oil diet

Intervention: 8 weeks of a plant-based, olive oil diet

Group Type: EXPERIMENTAL

Plant- based, olive oil diet

Intervention Type: OTHER

used as part of daily diet, followed for 8 weeks

Prostate Cancer Foundation diet

Intervention Type: OTHER

followed for 8 weeks

Interventions

Plant- based, olive oil diet

used as part of daily diet, followed for 8 weeks

Intervention Type: OTHER

Prostate Cancer Foundation diet

followed for 8 weeks

Intervention Type: OTHER

Other Intervention Names

plant-based, olive oil diet

Eligibility Criteria

Inclusion Criteria

• prostate cancer, BMI 25.0 to 40.0 kg/m2

Exclusion Criteria

-

• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

The Miriam Hospital

OTHER

Sponsor Role: lead

Responsible Party

Mary Flynn

Research dietitian, Associate professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mary M Flynn, PhD, RD

Role: PRINCIPAL_INVESTIGATOR

Research Dietitian

Other Identifiers

2134-14

Identifier Type: -

Identifier Source: org_study_id