Role of Race in Nutritional Approach in Men on ADT

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of California, Los Angeles
Study ID
NCT06682390
Status
Recruiting
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Conditions

  • Prostate Cancer Metastatic Disease

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Mar 28, 2024
Status verified
Nov 2025
Primary completion
Nov 20, 2027
Completion
Nov 29, 2027

Study Design

Enrollment
70 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • 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.

Primary Outcome Measure

Fat mass [ Time Frame: At baseline, 3 months and 6 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Greater Los Angeles Division of Veterans AffairsLos AngelesCalifornia90073
Zhaoping Li, MD, PhD
[email protected]
310-825-7921
Zhaoping Li, MD, PhD (PRINCIPAL_INVESTIGATOR)
Matthew Rettig, MD (PRINCIPAL_INVESTIGATOR)
UCLA Health 200 Medical PlazaLos AngelesCalifornia90095
Matthew Rettig, MD
[email protected]
310-794-7700
Matthew Rettig, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Los Angeles, CA

By research site
Greater Los Angeles Division of Veterans Affairs· Los Angeles, CAUCLA Health 200 Medical Plaza· Los Angeles, CA

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