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

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Lifespan

Status

Completed

Conditions

Prostate Cancer

Treatments

Other: Plant- based, olive oil diet
Other: Prostate Cancer Foundation diet

Study type

Interventional

Funder types

Other

Identifiers

NCT03084913
2134-14

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 patients

Sex

Male

Volunteers

No Healthy Volunteers

Inclusion criteria

  • prostate cancer, BMI 25.0 to 40.0 kg/m2

Exclusion criteria

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

30 participants in 2 patient groups

Prostate Cancer Foundation diet
Active Comparator group
Description:
Intervention: 8-weeks of a Prostate Cancer Foundation diet
Treatment:
Other: Prostate Cancer Foundation diet
Other: Plant- based, olive oil diet
plant- based, olive oil diet
Experimental group
Description:
Intervention: 8 weeks of a plant-based, olive oil diet
Treatment:
Other: Prostate Cancer Foundation diet
Other: Plant- based, olive oil diet

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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