Investigating the impact of diet on African American and white men with prostate cancer on hormone therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Fezolinetant to reduce hot flashes in men on androgen-deprivation therapy

  This trial will test whether taking fezolinetant once daily for 4 weeks reduces how often and how severe hot flashes are in men with prostate cancer who are on androgen-deprivation therapy.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.