NCT06682390Recruiting
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
Source: ClinicalTrials.gov · Last updated 15 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 70 (estimated)
- First submitted
- 7 Nov 2024
- Start date
- 28 Mar 2024
- Primary completion date
- 20 Nov 2027
- Lead sponsor
- University of California, Los Angeles
- Diseases
- Prostate cancer
- NCT number
- NCT06682390
What you commit to
- Study type: Interventional
- Planned participants: 70
- From 28 Mar 2024 to the primary completion date, 20 Nov 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Radiation or chemotherapy treatment
Other illness
- History of diabetes or serious medical condition including uncontrolled hypertension, liver, kidney, and cardiovascular disease
Lab values
- Any subject with a screening laboratory value outside of the laboratory normal range that is considered clinically significant for study participation by the investigator
Other
- Life expectancy \< 1 year
- Females
- 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
Who the study is looking for
- \>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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UCLA Health 200 Medical Plaza Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| Greater Los Angeles Division of Veterans Affairs Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.