Role of Race in Nutritional Approach in Men on ADT

Last updated: November 7, 2024
Sponsor: University of California, Los Angeles
Overall Status: Active - Recruiting

Phase

N/A

Condition

Neoplasm Metastasis

Treatment

Hypocaloric anti-inflammatory diet

Clinical Study ID

NCT06682390
22-001730
  • Ages > 18
  • Male

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.

Eligibility Criteria

Inclusion

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 informedconsent prior to the initiation of any study specific procedures or enrollment. Asubject will be excluded for any condition that might compromise the ability to givetruly informed consent

Exclusion

Exclusion Criteria:

  • Life expectancy < 1 year

  • Females

  • Radiation or chemotherapy treatment

  • History of diabetes or serious medical condition including uncontrolledhypertension, liver, kidney, and cardiovascular disease

  • Any subject with a screening laboratory value outside of the laboratory normal rangethat is considered clinically significant for study participation by theinvestigator

  • 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

Study Design

Total Participants: 70
Treatment Group(s): 1
Primary Treatment: Hypocaloric anti-inflammatory diet
Phase:
Study Start date:
March 28, 2024
Estimated Completion Date:
November 29, 2025

Connect with a study center

  • Greater Los Angeles Division of Veterans Affairs

    Los Angeles, California 90073
    United States

    Active - Recruiting

  • UCLA Health 200 Medical Plaza

    Los Angeles, California 90095
    United States

    Active - Recruiting

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