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NCT Number: NCT06682390

Role of Race in Nutritional Approach in Men on ADT

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.

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Key information

Conditions

Prostate Cancer Metastatic Disease

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Greater Los Angeles Division of Veterans Affairs, Los Angeles, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Fat mass

    Time frame: At baseline, 3 months and 6 months

    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.

  2. Waist circumference

    Time frame: At baseline, 3 months and 6 months

    Waist circumference will be measured with a tape measure in standing position horizontally, just above the hip bone, without compressing the skin.

Secondary outcomes

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

    Time frame: At baseline, 3 months and 6 months

    Blood lipids and lipoproteins will be analyzed spectrophotometrically using reagent from Pointe Scientific (Canton, MI, USA).

  2. HbA1c

    Time frame: At baseline, 3 months and 6 months

    HbA1c will be analyzed spectrophotometrically using reagent from Pointe Scientific (Canton, MI, USA).

  3. Total testosterone

    Time frame: At baseline, 3 months and 6 months

    Total testosterone will be analyzed spectrophotometrically using reagent from Pointe Scientific (Canton, MI, USA).

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

    Time frame: At baseline, 3 months and 6 months

    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.

  5. Serum free fatty acids

    Time frame: At baseline, 3 months and 6 months

    Serum free fatty acids will be measured using an enzymatic colorimetric assay according to manufacturer (Sigma-Aldrich, St. Louis, MI).

  6. Diet and physical activity

    Time frame: At baseline, 3 months and 6 months

    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.

Other outcomes

  1. Cancer-related fatigue

    Time frame: At baseline, 3 months and 6 months

    Participants will be asked to fill out a questionnaire about cancer-related fatigue.

  2. Quality of life

    Time frame: At baseline, 3 months and 6 months

    Participants will be asked to fill out a questionnaire about quality of life.

Study contacts

Contact information is provided by the study sponsor or research team.

Tatiana Diacova, PhD, MS, RDN

CONTACT

[email protected]

310-825-8499

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • National Comprehensive Cancer Network

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Nov 12, 2024
Registry last updated
Dec 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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