Recruiting

Nutritional Approach

Sponsor:

UCLA

Code:

NCT06682390

Conditions

Prostate Cancer Metastatic Disease

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Hypocaloric anti-inflammatory diet

Study Details

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. 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.

Conditions

Prostate Cancer Metastatic Disease

Study ID

NCT06682390

Start date

Mar 28, 2024

Status verified date

Nov, 2025

Completion date

Nov 29, 2027

Anticipated

Primary completion date

Nov 20, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

70 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

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.

Interventions

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Tatiana Diacova, PhD, MS, RDN

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

Locations

Greater Los Angeles Division of Veterans Affairs

Recruiting

Los Angeles, California, United States, 90073

Contacts

Zhaoping Li, MD, PhD

310-825-7921zli@mednet.ucla.edu

Principal Investigator:

Zhaoping Li, MD, PhD

UCLA Health 200 Medical Plaza

Recruiting

Los Angeles, California, United States, 90095

Contacts

Matthew Rettig, MD

310-794-7700mrettig@mednet.ucla.edu

Principal Investigator:

Matthew Rettig, MD

More Information

Sponsor

University of California, Los Angeles

Last update posted

Dec 15, 2025

Last verified

Nov, 2025

Keywords

  • ADT
  • cardiovascular risk factors

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of California, Los Angeles on 2025-12-15.