Plant-Based meals delivered to home may help prostate cancer patients fight weight gain
NCT ID NCT05471414
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at whether a whole-food, plant-based diet can help overweight or obese men with prostate cancer who are on hormone therapy (ADT) control their weight and reduce inflammation. About 76 men will either receive free plant-based meals at home or standard nutrition advice. The main goal is to see if the diet leads to weight loss after 4 weeks, with follow-ups up to 26 weeks.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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76 people
The number who actually took part.
- Started
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Sep 2022
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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45 to 99 years
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 phone
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Columbia University Medical Center
New York, New York, 10032, United States
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Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21231, United States
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Weill Cornell Medicine
New York, New York, 10021, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- A scanner in the operating room could show surgeons exactly where prostate cancer remains
- New PET tracer aims to light up hidden cancer targets
- Can daily adaptive radiotherapy spare healthy tissue in prostate cancer?
- Can a radioactive tracer and MRI reveal prostate Cancer's true extent?
- Five-Fraction radiation plus hormone therapy tested against High-Risk prostate cancer
- Can a 10-Hour eating window fight cancer fatigue?