Role of Race in Nutritional Approach in Men on ADT

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

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.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer Metastatic Disease
• Intervention / Treatment: Behavioral: Hypocaloric anti-inflammatory diet

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tatiana Diacova, PhD, MS, RDN; Phone Number: 310-825-8499; Email: tdiacova@mednet.ucla.edu

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90073
      • Recruiting
      • Greater Los Angeles Division of Veterans Affairs
      • Principal Investigator: Matthew Rettig, MD
      • Principal Investigator: Zhaoping Li, MD, PhD
      • Contact: Zhaoping Li, MD, PhD; Phone Number: 310-825-7921; Email: zli@mednet.ucla.edu
    • Los Angeles, California, United States, 90095
      • Recruiting
      • UCLA Health 200 Medical Plaza
      • Principal Investigator: Matthew Rettig, MD
      • Contact: Matthew Rettig, MD; Phone Number: 310-794-7700; Email: mrettig@mednet.ucla.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: Hypocaloric anti-inflammatory diet; The anti-inflammatory hypocaloric diet combines the exclusion of pro- inflammatory constituents and inclusion of anti-inflammatory nutrients. Excluded food items will be refined carbohydrates, soda and alcoholic beverages, ultra- processed foods, smoked foods, fatty foods, packaged foods, canned products, preservatives, emulsifiers, and sauces. Reduce or eliminate red/processed meats. Included food items will be a defined minimum diversity of fruits, vegetables, and nuts based on complementary phytonutrient contents, particularly those rich in phenolic compounds such as ellagitannins and sulforaphanes. Selected herbs (e.g., turmeric, ginger, garlic, black pepper, rosemary, cardamon, cinnamon), green tea, fermented foods, fats (e.g., avocado), and oils (e.g., olive oil) will be encouraged. The goal is to have 5 servings of vegetables, 2 fruits per day, and 5 vegetable color groups per week. Participants will also be asked to reduce their kcal by 500/day and walk for 1 gr 3x per week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fat mass	Bioelectric impedance measurement will provide information about body composition including percent body fat, fat mass, lean body mass, total body water and basal metabolic rate using the portable BIA310e (Biodynamics Corp.). BIA is based on the principle that the flow of an electrical current through an object can be used to determine the object's physical properties.	At baseline, 3 months and 6 months
Waist circumference	Waist circumference will be measured with a tape measure in standing position horizontally, just above the hip bone, without compressing the skin.	At baseline, 3 months and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood lipids and lipoproteins (triglycerides, total cholesterol, LDL cholesterol, HDL cholesterol)	Blood lipids and lipoproteins will be analyzed spectrophotometrically using reagent from Pointe Scientific (Canton, MI, USA).	At baseline, 3 months and 6 months
HbA1c	HbA1c will be analyzed spectrophotometrically using reagent from Pointe Scientific (Canton, MI, USA).	At baseline, 3 months and 6 months
Total testosterone	Total testosterone will be analyzed spectrophotometrically using reagent from Pointe Scientific (Canton, MI, USA).	At baseline, 3 months and 6 months
Inflammatory markers (hs-CRP, IL-6, IL-1b, TNFa)	Concentrations of hs-CRP and cytokines will be quantified using the MagPix® analyzer (Luminex, Austin TX) with MILLIPLEX MAP Human CVD Panel 3 kit (hs-CRP) and Milliplex Human Cytokine/Chemokine MAGNETIC BEAD kit (IL-6, IL-1β, TNFα,) from EMD Millipore (Billerica, MA) at the Center for Human Nutrition Biomarker Laboratory.	At baseline, 3 months and 6 months
Serum free fatty acids	Serum free fatty acids will be measured using an enzymatic colorimetric assay according to manufacturer (Sigma-Aldrich, St. Louis, MI).	At baseline, 3 months and 6 months
Diet and physical activity	Participants in both groups will be instructed to use the weekly checklist for logging intake, physical activity and sleep habits. Subjects will be encouraged to track dietary intake as often as possible and mandated to complete 3-day dietary record 2 times every 4 weeks. Activity/exercise and sleep time will be monitored by the provided weekly checklist and ASA-24 at baseline, month 3, and month 6.	At baseline, 3 months and 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cancer-related fatigue	Participants will be asked to fill out a questionnaire about cancer-related fatigue.	At baseline, 3 months and 6 months
Quality of life	Participants will be asked to fill out a questionnaire about quality of life.	At baseline, 3 months and 6 months

Collaborators and Investigators

• Sponsor: University of California, Los Angeles
• Collaborators: National Comprehensive Cancer Network
• Investigators: Principal Investigator: Zhaoping Li, MD, PhD, University of California, Los Angeles; Principal Investigator: Matthew Rettig, MD, Greater Los Angeles Division of Veterans Affairs, Los Angeles, California 90073

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2024
• Primary Completion (Estimated): November 20, 2027
• Study Completion (Estimated): November 29, 2027

Study Registration Dates

• First Submitted: November 7, 2024
• First Submitted That Met QC Criteria: November 7, 2024
• First Posted (Actual): November 12, 2024

Study Record Updates

• Last Update Posted (Actual): December 15, 2025
• Last Update Submitted That Met QC Criteria: December 8, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: ADT; cardiovascular risk factors
• Other Study ID Numbers: 22-001730

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No