Contribution of Race to Nutritional Approach to Lower Cardiovascular Risk Factors in Men Undergoing Androgen Deprivation Therapy

What this Trial Is About

Researchers are studying how race influences the effects of a special diet and exercise program on men with metastatic prostate cancer who are receiving androgen deprivation therapy (ADT). This research aims to compare changes in fat mass, cardiovascular risk factors like body weight and blood pressure, inflammation markers, cancer-related fatigue, and quality of life between African American and non-Hispanic white men on ADT. The study is a pilot, controlled, two-phase intervention that will enroll equal numbers of African American and non-Hispanic white men. The study has two phases lasting three months each. In the first phase, participants will maintain their usual diet and physical activity. In the second phase, they will follow a hypocaloric anti-inflammatory diet that reduces calorie intake by 500 calories per day and walk for one hour three times a week. The diet excludes refined carbohydrates, processed foods, and certain meats, while encouraging fruits, vegetables, nuts, herbs, and healthy fats. Participants will be assessed at the start, after three months, and after six months for fat mass, waist circumference, blood lipids, blood sugar (HbA1c), testosterone levels, inflammation markers, and physical activity. Patient-reported outcomes like fatigue and quality of life will also be measured. The study will monitor adherence to the diet and exercise regimen and evaluate differences by race in response to these interventions over six months.

Role of Race in Nutritional Approach in Men on ADT