Role of Race in Nutritional Approach in Men on ADT

NCT06682390 | Recruiting

• 1 other identifier: 22-001730
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

Brief 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. 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. 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. 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.

Conditions

Prostate Cancer Metastatic Disease

Keywords

ADT; cardiovascular risk factors

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Blood lipids and lipoproteins (triglycerides, total cholesterol, LDL cholesterol, HDL cholesterol)

  At baseline, 3 months and 6 months

• HbA1c

  At baseline, 3 months and 6 months

• Total testosterone

  At baseline, 3 months and 6 months

• Inflammatory markers (hs-CRP, IL-6, IL-1b, TNFa)

  At baseline, 3 months and 6 months

• Serum free fatty acids

  At baseline, 3 months and 6 months

Other Outcomes (2)

• Cancer-related fatigue

  At baseline, 3 months and 6 months

• Quality of life

  At baseline, 3 months and 6 months

Study Arms (2)

Habitual dietary and physical activity regimen

NO INTERVENTION

Participants will maintain their habitual dietary and physical activity regimen for the first 3 months of the study.

Hypocaloric anti-inflammatory diet

EXPERIMENTAL

Participants will follow a hypocaloric anti-inflammatory diet for the last 3 months of the study.

Behavioral: Hypocaloric anti-inflammatory diet

Interventions

Hypocaloric anti-inflammatory diet BEHAVIORAL

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.

Hypocaloric anti-inflammatory diet

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Comprehensive Cancer Network: collaborator
• University of California, Los Angeles: lead

Study Sites (2)

Greater Los Angeles Division of Veterans Affairs

Los Angeles, California, 90073, United States

RECRUITING

UCLA Health 200 Medical Plaza

Los Angeles, California, 90095, United States

RECRUITING

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tatiana Diacova, PhD, MS, RDN

CONTACT

310-825-8499; tdiacova@mednet.ucla.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: UCLA Professor of Medicine

Study Record Dates

• First Submitted: November 7, 2024
• First Posted: November 12, 2024
• Study Start: March 28, 2024
• Primary Completion (Estimated): November 20, 2027
• Study Completion (Estimated): November 29, 2027
• Last Updated: December 15, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)