Open Actively Recruiting

Role of Race in Nutritional Approach in Men on ADT

About

Brief Summary

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:

  • 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.
  • 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.
  • 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.

Primary Purpose
Other
Study Type
Interventional
Phase
N/A

Eligibility

Gender
Male
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

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

Join this Trial

Contact our clinical trial navigators for opportunities that may be suitable for you
Share:
Study Stats
Protocol No.
22-001730
Category
Prostate Cancer
Contact
Irene Gilbuena
Location
  • UCLA Westwood
For Providers
NCT No.
NCT06682390
For detailed technical eligibility, visit ClinicalTrials.gov.