Whole-Food Plant-Based Diet to Control Weight and MetaboInflammation in Overweight/Obese Men With… (NCT05471414) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Whole-Food Plant-Based Diet to Control Weight and MetaboInflammation in Overweight/Obese Men With Prostate Cancer
United States76 participantsStarted 2022-09-22
Plain-language 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).
Who can participate
Age range45 Years – 99 Years
SexMALE
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Inclusion criteria
✓. Histologically or cytologically confirmed adenocarcinoma of the prostate
✓. Receiving androgen deprivation therapy (ADT) with an LHRH/GnRH analogue (agonist/antagonist); or have undergone bilateral orchiectomy. Patients with localized prostate cancer, non-metastatic castrate resistant prostate cancer (CRPC), metastatic hormone sensitive prostate cancer and metastatic CRPC are all eligible.
✓. On ADT for at least 24 weeks pre-study with anticipation of at least 26 more weeks of therapy from the date of initiation of the dietary intervention
✓. Patients receiving an anti-androgen (including, but not limited to drugs such as bicalutamide, abiraterone, enzalutamide or apalutamide) are eligible if they have been on therapy for at least 3 months and plan to continue for the duration of the study
✓. At least 3 months post completion of chemotherapy and/or radiation
✓. Bone resorptive agents such as bisphosphanates and denosumab are allowed.
✓. Testosterone level \<50 ng/dL
✓. Age ≥ 45 years
Exclusion criteria
✕. Insulin-dependent diabetes mellitus
✕. Nut or legume allergy, gluten intolerance or celiac disease
✕. Currently consuming a vegetarian or vegan diet
✕
What they're measuring
1
Change in weight from baseline to 4 weeks post-randomization
Timeframe: Baseline; 4 weeks post-randomization
Trial details
NCT IDNCT05471414
SponsorWeill Medical College of Cornell University
. Concurrent participation in other nutrition or weight loss programs
✕. Expected changes in chronic medications, including statins or oral diabetes medication during the study period (including a change in medication dosage)
✕. Expected radiation, chemotherapy, bone resorptive agents or anti-androgen within 2 months of beginning the diet intervention
✕. Expected changes in exercise patterns during the study period
✕. Psychiatric illnesses or social situations that would limit compliance with study requirements, including a living situation that does not allow for the delivery of Plantable prepared meals, or the inability or lack of equipment to perform basic cooking tasks