Contribution of Race to Nutritional Approach to Lower Cardiovascular Risk Factors in Men Undergoing Androgen Deprivation Therapy

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• \>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

Locations
United States
California
Greater Los Angeles Division of Veterans Affairs
RECRUITING
Los Angeles
UCLA Health 200 Medical Plaza
RECRUITING
Los Angeles
Contact Information
Primary
Tatiana Diacova, PhD, MS, RDN
tdiacova@mednet.ucla.edu
310-825-8499
Time Frame
Start Date: 2024-03-28
Estimated Completion Date: 2025-11-29
Participants
Target number of participants: 70
Treatments
No_intervention: Habitual dietary and physical activity regimen
Participants will maintain their habitual dietary and physical activity regimen for the first 3 months of the study.
Experimental: Hypocaloric anti-inflammatory diet
Participants will follow a hypocaloric anti-inflammatory diet for the last 3 months of the study.
Related Therapeutic Areas
Sponsors
Leads: University of California, Los Angeles
Collaborators: National Comprehensive Cancer Network

This content was sourced from clinicaltrials.gov

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