Role of Race in Nutritional Approach in Men on ADT

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

There is a well-documented association between androgen deprivation therapy (ADT) and cardiovascular morbidity. A majority of men on ADT gain weight contributing to an increase in cardiovascular risk factors (CVRFs) and cardiovascular morbidity. Dietary intervention combined with exercise have shown success in reducing weight/fat mass and improving cardiovascular risk factors (CVRF). There is little data on whether African American men would respond to diet and exercise interventions differently from non-Hispanic white men. We will conduct a pilot, controlled two-phase intervention study stratified by race to investigate the following objectives:

1. Compare effect of a hypocaloric, anti-inflammatory diet on changes in fat mass between African- American vs non-Hispanic white men with metastatic prostate cancer on ADT therapy.
2. Compare effect of a hypocaloric, anti-inflammatory diet on changes in cardiovascular risk factors (body weight, lean body mass, waist-to-height ratio, blood pressure, lipids and HbA1C) and inflammatory markers (hs-CRP and cytokines) between African-American vs non-Hispanic white men with metastatic prostate cancer on ADT therapy.
3. Compare effect of a hypocaloric, anti-inflammatory diet on changes in cancer-related fatigue and quality of life between African-American vs non-Hispanic white men with metastatic prostate cancer on ADT therapy.

We will enroll 35 African American and 35 non-Hispanic white men with prostate cancer undergoing ADT therapy. In phase 1, after baseline assessment, men will consume their habitual diet and continue their habitual activity level for 3 months. During phase 2, participants will be instructed to consume a hypocaloric (-500 kcal), anti- inflammatory diet and walk for 1 hour on 3 days per week for 3 months. At baseline, after phase 1 and 2 primary outcome (fat mass) and secondary outcomes (CVRF and inflammatory markers) and tertiary outcomes (cancer-related fatigue and quality of life) will be determined.

Inclusion Criteria:

• >12 months on ADT
• Expected continuation of ADT for >6 months upon initiation of study procedures
• Serum testosterone <50 ng/dL
• BMI >25
• Age >18 years old
• African American and Non-Hispanic white males
• Subjects must read and sign the Institutional Review Board-approved written informed consent prior to the initiation of any study specific procedures or enrollment. A subject will be excluded for any condition that might compromise the ability to give truly informed consent

Exclusion Criteria:

• Life expectancy < 1 year
• Females
• Radiation or chemotherapy treatment
• History of diabetes or serious medical condition including uncontrolled hypertension, liver, kidney, and cardiovascular disease
• Any subject with a screening laboratory value outside of the laboratory normal range that is considered clinically significant for study participation by the investigator
• Any subject who currently uses tobacco products
• Any use of >20 g of alcohol per day
• Any subject who is unable or unwilling to comply with the study protocol
• Any subject who is unable to provide consent