Actively Recruiting
Role of Race in Nutritional Approach in Men on ADT
Led by University of California, Los Angeles · Updated on 2025-12-15
70
Participants Needed
2
Research Sites
191 weeks
Total Duration
On this page
Sponsors
U
University of California, Los Angeles
Lead Sponsor
N
National Comprehensive Cancer Network
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Role of Race in Nutritional Approach in Men on ADT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- On androgen deprivation therapy (ADT) for more than 12 months
- Expected to continue ADT for more than 6 months after starting this study
- Serum testosterone level less than 50 ng/dL
- Body mass index (BMI) greater than 25
- Male, aged 18 years or older
- African American or Non-Hispanic white male
- Able to read and sign informed consent before starting study procedures
You will not qualify if you...
- Life expectancy less than 1 year
- Female
- Receiving radiation or chemotherapy treatment
- History of diabetes or serious medical conditions including uncontrolled high blood pressure, liver, kidney, or cardiovascular disease
- Any abnormal lab test considered clinically significant by the investigator
- Current use of tobacco products
- Consuming more than 20 grams of alcohol per day
- Unable or unwilling to follow the study protocol
- Unable to provide informed consent
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Greater Los Angeles Division of Veterans Affairs
Los Angeles, California, United States, 90073
Actively Recruiting
2
UCLA Health 200 Medical Plaza
Los Angeles, California, United States, 90095
Actively Recruiting
Research Team
T
Tatiana Diacova, PhD, MS, RDN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
2
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