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NCT06682390NARecruiting

Role of Race in Nutritional Approach in Men on ADT

University of California, Los Angeles

Start Date

3/28/2024

Completion Date

11/29/2027

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

Age Range: 18 years to No maximum

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

Interventions

BEHAVIORAL

Hypocaloric anti-inflammatory diet

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Conditions

Prostate Cancer Metastatic Disease

Locations

Greater Los Angeles Division of Veterans Affairs

Los Angeles, California 90073

United States

UCLA Health 200 Medical Plaza

Los Angeles, California 90095

United States