Whole-food, Plant-based Diet (WFPBD) for Prostate Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Columbia University Medical Center, New York, NY
Prostate Cancer+1 More
Whole-food, Plant-Based Diet - Behavioral
Eligibility
18+
Male
What conditions do you have?
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Study Summary

The study is comparing the effect on weight of providing home-delivered whole-food, plant-based meals versus standard, general nutritional counseling to men with prostate cancer on androgen-deprivation therapy (ADT).

Eligible Conditions

  • Prostate Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 16 Secondary · Reporting Duration: Baseline; 4, 8, and 26 weeks post-randomization

Week 26
Change in mean body mass including fat, as determined by DEXA scan, from baseline to 4 and 26 weeks post-randomization.
Change in mean fat free body mass, as determined by DEXA scan, from baseline to 4 and 26 weeks post-randomization.
Change in mean measures of body fat percentage, as determined by DEXA scan, from baseline to 4 and 26 weeks post-randomization
Change in the diversity of the fecal microbiome from baseline to 4 and 26 weeks post-randomization
Baseline; 4 weeks post-randomization
Change in weight from baseline to 4 weeks post-randomization
Week 26
Change in BMI from baseline to 4, 8, and 26 weeks post-randomization.
Change in FACT-P score as an indicator of quality of life from baseline to 4, 8, and 26
Change in levels of HDL from baseline to 4, 8, and 26 weeks post-randomization
Change in levels of fasting triglycerides from baseline to 4, 8, and 26 weeks post-randomization
Change in levels of hemoglobin A1c from baseline to 4, 8, and 26 weeks post-randomization
Change in levels of serum IL-6 from baseline to 4, 8, and 26 weeks post-randomization
Change in levels of serum adiponectin from baseline to 4, 8, and 26 weeks post-randomization
Change in levels of serum direct LDL from baseline to 4, 8, and 26 weeks post-randomization
Change in levels of serum glucose from baseline to 4, 8, and 26 weeks post-randomization
Change in levels of serum hsCRP from baseline to 4, 8, and 26 weeks post-randomization
Change in levels of serum insulin from baseline to 4, 8, and 26 weeks post-randomization
Change in levels of serum leptin from baseline to 4, 8, and 26 weeks post-randomization

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

General Nutrition Counseling
1 of 2
Whole-food, Plant-based Diet (WFPBD)
1 of 2
Active Control
Experimental Treatment

60 Total Participants · 2 Treatment Groups

Primary Treatment: Whole-food, Plant-based Diet (WFPBD) · No Placebo Group · N/A

Whole-food, Plant-based Diet (WFPBD)
Behavioral
Experimental Group · 1 Intervention: Whole-food, Plant-Based Diet · Intervention Types: Behavioral
General Nutrition Counseling
Behavioral
ActiveComparator Group · 1 Intervention: General Nutritional Counseling · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline; 4, 8, and 26 weeks post-randomization
Closest Location: Columbia University Medical Center · New York, NY
Photo of columbia university medical center  1Photo of columbia university medical center  2Photo of columbia university medical center  3
2002First Recorded Clinical Trial
17 TrialsResearching Prostate Cancer
932 CompletedClinical Trials

Eligibility Criteria

Age 18+ · Male Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have adenocarcinoma of the prostate.
You are receiving an anti-androgen (including, but not limited to drugs such as bicalutamide, abiraterone, enzalutamide or apalutamide) and are planning to continue for the duration of the study.
You have completed chemotherapy and/or radiation therapy and are free of disease.
Testosterone level is less than 50 ng/dL.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.