Role of Race in Nutritional Approach in Men on ADT

Clinicaltrials.gov ID: NCT06682390

Status RECRUITING

Phase NA

Age ≥ 18 Years

Enrollments 70

Conditions

Prostate Cancer Metastatic Disease

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.

Locations

2 locations Found with status Recruiting

Status

RECRUITING

Contact Person

Zhaoping Li, MD, PhD
310-825-7921
[email protected]

Principal Investigator

Zhaoping Li, MD, PhD

Status

RECRUITING

Contact Person

Matthew Rettig, MD
310-794-7700
[email protected]

Principal Investigator

Zhaoping Li, MD, PhD

Eligibility Criteria

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

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
Description:
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.