Role of Race in Nutritional Approach in Men on ADT
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Hypocaloric anti-inflammatory diet.
- Who it may be relevant to
- Registry conditions: Prostate Cancer Metastatic Disease. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Contribution of Race to Nutritional Approach to Lower Cardiovascular Risk Factors in Men Undergoing Androgen Deprivation Therapy
Overview
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.
Interventions
- Behavioral 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 p
Primary outcome measures
- Fat mass [Time frame: At baseline, 3 months and 6 months]
- Waist circumference [Time frame: At baseline, 3 months and 6 months]
Secondary outcome measures (6)
- Blood lipids and lipoproteins (triglycerides, total cholesterol, LDL cholesterol, HDL cholesterol) [Time frame: At baseline, 3 months and 6 months]
- HbA1c [Time frame: At baseline, 3 months and 6 months]
- Total testosterone [Time frame: At baseline, 3 months and 6 months]
- Inflammatory markers (hs-CRP, IL-6, IL-1b, TNFa) [Time frame: At baseline, 3 months and 6 months]
- Serum free fatty acids [Time frame: At baseline, 3 months and 6 months]
- Diet and physical activity [Time frame: At baseline, 3 months and 6 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 2 centers
- Greater Los Angeles Division of Veterans Affairs — Los Angeles
- UCLA Health 200 Medical Plaza — Los Angeles
Identifiers
NCT: NCT06682390 · 22-001730