Clinical trial · Interventional
Whole Food Plant-based Diet to Improve Outcomes in Prostate Cancer
- 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 purpose of this research is to determine if consuming a whole food plant-based diet for six months impacts outcomes in men with prostate cancer that have a rising prostate-specific antigen (PSA) level. The main questions it aims to answer are: Does a whole-food plant-based impact PSA? Does a whole food plant-based diet impact risk factors associated with treatment for prostate cancer including LDL cholesterol, hemoglobin A1C, C-reactive protein? Participants will be asked to attend twelve two-hour plant-based cooking and nutrition classes throughout a six-month period, consume a mostly whole food plant-based diet, provide blood samples, and complete three-day food journals to assess nutrient intake.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Whole Food Plant-based Diet | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Whole Food Plant-based Diet
- interventionNames
- Other: Whole Food Plant-based Diet
Primary outcomes (1)
- measure
- Prostate Specific Antigen
- timeFrame
- 6 months
Secondary outcomes (3)
- measure
- LDL-cholesterol
- timeFrame
- 6 months
- description
- mg/dL
- measure
- Hemoglobin A1C
- timeFrame
- 6 months
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 45 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: * Males 45-99 years of age * Histologically or cytologically confirmed adenocarcinoma of the prostate * Increasing PSA on at least 2 sequential tests not more than 6 months apart. * Eastern Cooperative Oncology Group Performance Status Scale of 0 to 2 * Adequate organ and marrow function, based upon meeting all of the following laboratory criteria: * White blood cell count ≥ 2500/mm3 (≥ 2.5 GI/L) * Platelets ≥ 50,000/mm3 (≥ 100 GI/L) without transfusion * Hemoglobin ≥ 9 g/dL (≥ 90 g/L) * Alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin ≤ 2x upper limit of normal (or for subjects with Gilbert's syndrome direct bilirubin WNL) Serum albumin ≥ 2.8 g/dl * Willingness and ability to comply with all study-related procedures * Capable of understanding and complying with the protocol requirements and must have signed the informed consent document Exclusion Criteria: * Nut or legume allergy * Currently consuming a vegetarian or vegan diet * Concurrent participation in other nutrition or weight loss programs * Expected changes in exercise patterns during the study period * Active prostatitis * Insulin-dependent or requiring diabetes mellitus * 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 * Known history of electrolyte imbalance or micronutrient deficiency, e.g., magnesium, cobalamin * Ongoing use of warfarin anticoagulants * Diagnosed, active inflammatory bowel disease * Alcohol and/or drug abuse * Psychiatric illnesses or social situations that would limit compliance with study requirements including the inability or lack of equipment to perform basic cooking tasks
References
Publications (0)
Data not yet available