Clinical trial · Interventional
Whole-Food Plant-Based Diet to Control Weight and MetaboInflammation in Overweight/Obese Men With Prostate Cancer
Whole-Food Plant-Based Diet (WFPBD) to Control Weight and Metabo-Inflammation in Overweight/Obese Men With Prostate Cancer Receiving Androgen Deprivation Therapy (ADT): A Multi-Center Randomized Control Trial
NCT05471414CI-TRIAL-00114903WFPBDactive not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| General Nutritional Counseling | Behavioral | — | UNRESOLVED |
| Whole-food, Plant-Based Diet | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Whole-food, Plant-based Diet (WFPBD)
- description
- Home-delivered WFPBD meals will be provided to participants, along with nutritional coaching and education. 12 meals a week will be delivered for the first 4 weeks, followed by 6 meals a week for the next 4 weeks. Finally, for the last 18 weeks they will not receive pre-packed meals, but will continue to receive WFPBD coaching. 30 participants are anticipated to be accrued in this arm.
- interventionNames
- Behavioral: Whole-food, Plant-Based Diet
- type
- ACTIVE_COMPARATOR
- label
- General Nutrition Counseling
- description
- Participants will receive general nutritional counseling weekly for the first 4 weeks, followed by monthly nutritional counseling for the following 18 weeks. 30 participants are anticipated to be accrued in this arm.
- interventionNames
- Behavioral: General Nutritional Counseling
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 45 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria
1. Histologically or cytologically confirmed adenocarcinoma of the prostate
2. 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.
3. 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
4. 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
5. At least 3 months post completion of chemotherapy and/or radiation
6. Bone resorptive agents such as bisphosphanates and denosumab are allowed.
7. Testosterone level \<50 ng/dL
8. Age ≥ 45 years
9. BMI ≥ 27
10. ECOG performance status of 0 to 1
11. Adequate organ and marrow function, based upon meeting all of the following laboratory criteria:
1. White blood cell count ≥ 2500/mm3 (≥ 2.5 GI/L)
2. Platelets ≥ 100,000/mm3 (≥ 100 GI/L) without transfusion
3. Hemoglobin ≥ 9 g/dL (≥ 90 g/L)
4. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin ≤ 2x ULN (or for subjects with Gilbert's disease direct bilirubin WNL) Note: Subjects with elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) (up to 5x ULN) will be eligible if elevation is felt to be due to fatty liver disease related to obesity.
5. Serum albumin ≥ 2.8 g/dl
12. Willingness and ability to comply with all study-related procedures
13. Capable of understanding and complying with the protocol requirements and must have signed the informed consent document
Exclusion Criteria
1. Insulin-dependent diabetes mellitus
2. Nut or legume allergy, gluten intolerance or celiac disease
3. Currently consuming a vegetarian or vegan diet
4. Concurrent participation in other nutrition or weight loss programs
5. Expected changes in chronic medications, including statins or oral diabetes medication during the study period (including a change in medication dosage)
6. Expected radiation, chemotherapy, bone resorptive agents or anti-androgen within 2 months of beginning the diet intervention
7. Expected changes in exercise patterns during the study period
8. 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
9. Known history of electrolyte imbalance or micronutrient deficiency, e.g., magnesium, cobalamin
10. Ongoing use of warfarin anticoagulants
11. Diagnosed, active inflammatory bowel disease
12. Inability to receive Emails or have a smart phoneReferences
Publications (0)
Data not yet available
No reference posted for this study.