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Dietary Approach for Men on ADT

This study is looking at how a special diet, called a hypocaloric anti-inflammatory diet, affects men who are receiving androgen deprivation therapy (ADT) for metastatic prostate cancer. ADT can cause weight gain and increase the risk of heart problems. This diet aims to reduce weight and improve heart health by excluding certain foods like refined carbohydrates and processed foods, and including anti-inflammatory nutrients. Researchers want to see if African American men respond to this diet differently than non-Hispanic white men. The study will measure changes in body fat and waist size over six months. We are looking for 70 men to participate.

Study design
This is a pilot study that will include 70 participants. It is designed to compare the effects of a specific diet in African American and non-Hispanic white men.
What's involved
Participants will follow a hypocaloric anti-inflammatory diet. Measurements of fat mass and waist circumference will be taken at the start, at 3 months, and at 6 months.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 6 months, with measurements taken at baseline, 3 months, and 6 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06682390

Role of Race in Nutritional Approach in Men on ADT

Recruiting
NAAges 18+Interventional
University of California, Los Angeles
~70 participants
Updated 2025-12-15 on ClinicalTrials.gov
What's tested:Hypocaloric anti-inflammatory diet

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Fat mass
Measured over At baseline, 3 months and 6 months
+1 more outcome measured

Conditions

Prostate Cancer Metastatic Disease

Explore related trials

Prostate CarcinomaTestosterone

Where it's being run

2 sites across 1 states
California2

Study leadership

  • Zhaoping Li, MD, PhD · PRINCIPAL_INVESTIGATOR · University of California, Los Angeles
  • Matthew Rettig, MD · PRINCIPAL_INVESTIGATOR · Greater Los Angeles Division of Veterans Affairs, Los Angeles, California 90073

Who to contact

Tatiana Diacova, PhD, MS, RDN
[email protected]
310-825-8499
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

\>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

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

What this trial measures

  • Fat massAt baseline, 3 months and 6 months

    Bioelectric impedance measurement will provide information about body composition including percent body fat, fat mass, lean body mass, total body water and basal metabolic rate using the portable BIA310e (Biodynamics Corp.). BIA is based on the principle that the flow of an electrical current through an object can be used to determine the object's physical properties.

  • Waist circumferenceAt baseline, 3 months and 6 months

    Waist circumference will be measured with a tape measure in standing position horizontally, just above the hip bone, without compressing the skin.