NCT05471414

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: Weill Medical College of Cornell University · Academic / Other
• Sex: Male
• Age: 45 Years – 99 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
BEHAVIORAL	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.
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.

Timeline

• Start date: 2022-09-22
• Primary completion: 2026-04-01
• Completion: 2027-04-01
• First posted: 2022-07-22
• Last updated: 2026-01-22

Locations

3 sites across 1 country: United States