NCT06682390 Role of Race in Nutritional Approach in Men on ADT
| NCT ID | NCT06682390 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, Los Angeles |
| Condition | Prostate Cancer Metastatic Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2024-03-28 |
| Primary Completion | 2027-11-20 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 70 participants in total. It began in 2024-03-28 with a primary completion date of 2027-11-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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: 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.
Eligibility 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
Contact & Investigator
Zhaoping Li, MD, PhD
PRINCIPAL INVESTIGATOR
University of California, Los Angeles
Frequently Asked Questions
Who can join the NCT06682390 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Prostate Cancer Metastatic Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06682390 currently recruiting?
Yes, NCT06682390 is actively recruiting participants. Contact the research team at tdiacova@mednet.ucla.edu for enrollment information.
Where is the NCT06682390 trial being conducted?
This trial is being conducted at Los Angeles, United States, Los Angeles, United States.
Who is sponsoring the NCT06682390 clinical trial?
NCT06682390 is sponsored by University of California, Los Angeles. The principal investigator is Zhaoping Li, MD, PhD at University of California, Los Angeles. The trial plans to enroll 70 participants.
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