Investigating the impact of diet on African American and white men with prostate cancer on hormone therapy
Contribution of Race to Nutritional Approach to Lower Cardiovascular Risk Factors in Men Undergoing Androgen Deprivation Therapy
This study is testing if a special diet can help African American and white men with prostate cancer on hormone therapy lose weight and improve heart health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | University of California, Los Angeles Academic / other |
| Drugs / interventions | chemotherapy, Radiation |
| Locations | 2 sites (Los Angeles, California and 1 other locations) |
| Trial ID | NCT06682390 on ClinicalTrials.gov |
What this trial studies
This study aims to explore how a hypocaloric, anti-inflammatory diet affects fat mass and cardiovascular risk factors in African American and non-Hispanic white men undergoing androgen deprivation therapy (ADT) for metastatic prostate cancer. It will compare the dietary intervention's effectiveness between the two racial groups to determine if there are significant differences in response. The study will involve a controlled, two-phase intervention approach, focusing on weight management and cardiovascular health improvements. Participants must have been on ADT for over a year and meet specific health criteria to be eligible.
Who should consider this trial
Good fit: Ideal candidates are African American and non-Hispanic white males over 18 years old who have been on ADT for more than 12 months and have a BMI greater than 25.
Not a fit: Patients with a life expectancy of less than one year, serious medical conditions, or those currently undergoing radiation or chemotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to tailored dietary recommendations that improve health outcomes for men on ADT, particularly addressing cardiovascular risks.
How similar studies have performed: While there is limited data specifically on racial differences in dietary response among men on ADT, similar dietary interventions have shown success in improving health outcomes in other populations.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Los Angeles, California and 1 other locations
- Greater Los Angeles Division of Veterans Affairs — Los Angeles, California, United States (Recruiting)
- UCLA Health 200 Medical Plaza — Los Angeles, California, United States (Recruiting)
Study contacts
- Principal investigator: Zhaoping Li, MD, PhD — University of California, Los Angeles
- Study coordinator: Tatiana Diacova, PhD, MS, RDN
- Email: tdiacova@mednet.ucla.edu
- Phone: 310-825-8499
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.