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NCT06682390 · ClinicalTrials.gov registry record · NA
Role of Race in Nutritional Approach in Men on ADT
A NA study of Prostate Cancer Metastatic Disease, sponsored by University of California, Los Angeles.
- Recruiting
- Registry status
- NA
- Development phase
- 70
- Enrollment target
- 2
- Study locations
NCT06682390 is a NA study of Prostate Cancer Metastatic Disease that is actively recruiting participants, run by University of California, Los Angeles. The registered enrollment target is 70 participants, above the 41-participant average among 5 other Prostate Cancer Metastatic Disease trials with a reported enrollment target (71% higher). The trial reports 2 study locations across 1 state.
The verdict
NCT06682390, a NA study of Prostate Cancer Metastatic Disease, is actively recruiting participants, sponsored by University of California, Los Angeles.
- RECRUITING
- Registry status
- NA
- Development phase
- 70 participants
- Enrollment target
- 2
- Study locations
Study 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.
Conditions Studied
Interventions
- BEHAVIORAL Hypocaloric anti-inflammatory diet
Study Locations (2)
California
- Greater Los Angeles Division of Veterans Affairs - Los Angeles
- UCLA Health 200 Medical Plaza - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2024-03-28 |
| Est. Completion | 2027-11-29 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06682390
The ClinicalTrials.gov registry entry for NCT06682390 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 41-participant average among 5 other Prostate Cancer Metastatic Disease trials with a reported enrollment target (71% higher). The listed sponsor is University of California, Los Angeles, which has 897 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Prostate Cancer Metastatic Disease appearing as the primary indexed condition, and to 1 intervention - of which Hypocaloric anti-inflammatory diet is the first listed.
NCT06682390 reports 2 study locations spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT06682390 about?
NCT06682390 is a clinical study titled "Role of Race in Nutritional Approach in Men on ADT". 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...
What is the current status of trial NCT06682390?
This trial is currently recruiting. It is a NA study. The enrollment target is 70 participants. The study started on 2024-03-28. Estimated completion is 2027-11-29.
What conditions does trial NCT06682390 study?
This clinical trial studies the following conditions: Prostate Cancer Metastatic Disease.
What interventions are being tested in trial NCT06682390?
The interventions under investigation include: Hypocaloric anti-inflammatory diet (BEHAVIORAL).
Who is sponsoring clinical trial NCT06682390?
This trial is sponsored by University of California, Los Angeles, which has 897 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06682390 being conducted?
This trial has 2 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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