RightFit
RecruitingNot applicable

Role of Race in Nutritional Approach in Men on ADT

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 3 months

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests a lower-calorie diet meant to reduce inflammation, along with walking, in men with prostate cancer that has spread. It compares African American and non-Hispanic white men taking androgen deprivation therapy (ADT), a treatment that lowers testosterone. Researchers will look at body fat, heart health risks, tiredness, and quality of life.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have been on ADT for more than 12 months.
  • Expect to stay on ADT for more than 6 months after starting the study.
  • Have a blood testosterone level below 50 ng/dL.
  • Have a body mass index (BMI), a measure of weight compared with height, above 25.
  • Be older than 18.
  • Be an African American or non-Hispanic white man.
  • Be able to understand the study and read and sign the consent form before any study procedures.

Who can't join

  • Be expected to live less than 1 year.
  • Be female.
  • Be receiving radiation or chemotherapy.
  • Have a history of diabetes or a serious health problem, including uncontrolled high blood pressure or liver, kidney, or heart and blood vessel disease.
  • Have an abnormal screening lab result that the study doctor considers important for taking part.
  • Currently use tobacco products.
  • Drink more than 20 grams of alcohol per day.
  • Be unable or unwilling to follow study instructions, or unable to give consent.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 sites (2)

CA