Whole-Food Plant-Based Diet to Control Weight and MetaboInflammation in Overweight/Obese Men With Prostate Cancer

NCT ID: NCT05471414

Last Updated: 2026-01-22

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-22
• Study Completion Date: 2027-04-30

Brief 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).

Detailed Description

Prostate cancer is the most common cancer diagnosis for men in the United States. For patients with advanced or recurrent disease, ADT has is the cornerstone of systemic treatment. Overall, almost half of prostate cancer patients will undergo ADT at some point during their treatment. Unfortunately, ADT has metabolic side effects, including weight gain, central adiposity, and insulin resistance. This study is a multi-site randomized phase II trial comparing a home-delivered whole food, plant-based diet (WFPBD) with specialized behavioral coaching to standard dietary intervention with general nutritional counseling to assess the efficacy of a WFPBD in promoting weight loss in overweight/obese men receiving ADT. The home-delivered WFPBD will be for 28 days with 12 meals a week followed by 28 days with 6 meals a week; followed by self-prepared WFPBD for 18 weeks (for a total of 26 weeks).

The study hypothesis is that a WFPBD will decrease body weight and decrease systemic metabo-inflammation in overweight/obese men (BMI > 27) with prostate cancer receiving ADT. Secondary objectives will be to assess the effects of a WFPBD on adiposity, markers of inflammation (hsCRP, IL-6), metabolism (insulin, glucose, leptin, adiponectin), and fecal microbiota that may contribute to prostate cancer progression; to assess the effects of a WFPBD on quality of life; and to assess the durability of any observed effect (weight, adiposity, markers of inflammation and metabolism, fecal microbiota) of the intervention after cessation of the meal-delivery service.

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Whole-food, Plant-based Diet (WFPBD)

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.

Group Type: EXPERIMENTAL

Whole-food, Plant-Based Diet

Intervention Type: BEHAVIORAL

Pre-packaged, freshly made plant-based meals (provided by either Plantable or CookUnity) will be delivered weekly to participants' homes for 8 weeks. Meals are made with whole ingredients including whole grains, vegetables, legumes, nuts and seeds. Added sugar, animal-based products, refined grains, and processed foods are not used in any meal. Participants will be coached via phone calls, SMS, emails, and the app throughout the intervention to prepare meals in accordance with the diet. Participants will have access to a Registered Dietitian. During the first 4 weeks, 12 meals/week will be provided to participants; followed by 6 meals/week for the next 4 weeks; followed by 18 weeks where participants will continue to receive coaching, but will be expected to make all their own whole-food, plant-based meals with staff assistance available.

General Nutrition Counseling

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.

Group Type: ACTIVE_COMPARATOR

General Nutritional Counseling

Intervention Type: BEHAVIORAL

All study participants will receive consult with a Registered Dietitian at the Baseline visit and visit 1 study assessments. After visit 1, study participants assigned to the general nutritional counseling arm will receive an additional in-person or telehealth consultation with a Registered Dietitian that will consist of identification and counseling to improve diet quality and achieve a healthy body weight consistent with American Cancer Society guidelines.

Study participants in the control group will continue to receive general nutritional counseling and education with weekly scheduled telephone consultations with a Registered Dietitian for the first 4 weeks of the study period. For the remainder of the study period, they will receive counseling and education from Registered Dietitians via monthly scheduled phone calls.

Interventions

Whole-food, Plant-Based Diet

Pre-packaged, freshly made plant-based meals (provided by either Plantable or CookUnity) will be delivered weekly to participants' homes for 8 weeks. Meals are made with whole ingredients including whole grains, vegetables, legumes, nuts and seeds. Added sugar, animal-based products, refined grains, and processed foods are not used in any meal. Participants will be coached via phone calls, SMS, emails, and the app throughout the intervention to prepare meals in accordance with the diet. Participants will have access to a Registered Dietitian. During the first 4 weeks, 12 meals/week will be provided to participants; followed by 6 meals/week for the next 4 weeks; followed by 18 weeks where participants will continue to receive coaching, but will be expected to make all their own whole-food, plant-based meals with staff assistance available.

Intervention Type: BEHAVIORAL

General Nutritional Counseling

All study participants will receive consult with a Registered Dietitian at the Baseline visit and visit 1 study assessments. After visit 1, study participants assigned to the general nutritional counseling arm will receive an additional in-person or telehealth consultation with a Registered Dietitian that will consist of identification and counseling to improve diet quality and achieve a healthy body weight consistent with American Cancer Society guidelines.

Study participants in the control group will continue to receive general nutritional counseling and education with weekly scheduled telephone consultations with a Registered Dietitian for the first 4 weeks of the study period. For the remainder of the study period, they will receive counseling and education from Registered Dietitians via monthly scheduled phone calls.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Plantable Inc.

UNKNOWN

Sponsor Role: collaborator

Prostate Cancer Foundation

OTHER

Sponsor Role: collaborator

CookUnity

UNKNOWN

Sponsor Role: collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David M Nanus, MD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, United States

Weill Cornell Medicine

New York, New York, United States

Columbia University Medical Center

New York, New York, United States

Countries

United States

Other Identifiers

20-07022346

Identifier Type: -

Identifier Source: org_study_id