Prostate Cancer Metastatic DiseaseNCT06682390
Role of Race in Nutritional Approach in Men on ADT
A study testing Hypocaloric anti-inflammatory diet in people with Prostate Cancer Metastatic Disease, run by University of California, Los Angeles at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer Metastatic Disease
- What is being tested?
- Hypocaloric anti-inflammatory diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 2 sitesUnited States
- Study dates
- 28 Mar 2024to 29 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Greater Los Angeles Division of Veterans Affairs
Los Angeles, California, 90073
Zhaoping Li, MD, PhD, 310-825-7921, zli@mednet.ucla.edu
Zhaoping Li, MD, PhD
- Recruiting
UCLA Health 200 Medical Plaza
Los Angeles, California, 90095
Matthew Rettig, MD, 310-794-7700, mrettig@mednet.ucla.edu
Matthew Rettig, MD
About this study
Official title: Contribution of Race to Nutritional Approach to Lower Cardiovascular Risk Factors in Men Undergoing Androgen Deprivation Therapy
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:
- 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.
- 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.
- 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
- Being tested
- Hypocaloric anti-inflammatory diet
- Keywords
- ADT, cardiovascular risk factors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypocaloric anti-inflammatory dietBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Hypocaloric anti-inflammatory diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fat mass
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.
Measured: At baseline, 3 months and 6 months
Waist circumference
Waist circumference will be measured with a tape measure in standing position horizontally, just above the hip bone, without compressing the skin.
Measured: At baseline, 3 months and 6 months
Secondary outcomes (6)
Blood lipids and lipoproteins (triglycerides, total cholesterol, LDL cholesterol, HDL cholesterol)
Blood lipids and lipoproteins will be analyzed spectrophotometrically using reagent from Pointe Scientific (Canton, MI, USA).
Measured: At baseline, 3 months and 6 months
HbA1c
HbA1c will be analyzed spectrophotometrically using reagent from Pointe Scientific (Canton, MI, USA).
Measured: At baseline, 3 months and 6 months
Total testosterone
Total testosterone will be analyzed spectrophotometrically using reagent from Pointe Scientific (Canton, MI, USA).
Measured: At baseline, 3 months and 6 months
Inflammatory markers (hs-CRP, IL-6, IL-1b, TNFa)
Concentrations of hs-CRP and cytokines will be quantified using the MagPix® analyzer (Luminex, Austin TX) with MILLIPLEX MAP Human CVD Panel 3 kit (hs-CRP) and Milliplex Human Cytokine/Chemokine MAGNETIC BEAD kit (IL-6, IL-1β, TNFα,) from EMD Millipore (Billerica, MA) at the Center for Human Nutrition Biomarker Laboratory.
Measured: At baseline, 3 months and 6 months
Serum free fatty acids
Serum free fatty acids will be measured using an enzymatic colorimetric assay according to manufacturer (Sigma-Aldrich, St. Louis, MI).
Measured: At baseline, 3 months and 6 months
Diet and physical activity
Participants in both groups will be instructed to use the weekly checklist for logging intake, physical activity and sleep habits. Subjects will be encouraged to track dietary intake as often as possible and mandated to complete 3-day dietary record 2 times every 4 weeks. Activity/exercise and sleep time will be monitored by the provided weekly checklist and ASA-24 at baseline, month 3, and month 6.
Measured: At baseline, 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start28 Mar 2024
- Primary completion20 Nov 2027 (estimated)
- Study completion29 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer Metastatic DiseaseStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Comprehensive Cancer Network
- Responsible party
- Principal investigator, Zhaoping Li, University of California, Los Angeles
- Investigators
- Zhaoping Li, MD, PhD, Principal investigator, University of California, Los AngelesMatthew Rettig, MD, Principal investigator, Greater Los Angeles Division of Veterans Affairs, Los Angeles, California 90073
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06682390
- Sponsor's protocol ID
- 22-001730
- Status last verified
- Nov 2025
- First submitted
- 7 Nov 2024
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contribution of Race to Nutritional Approach to Lower Cardiovascular Risk Factors in Men Undergoing Androgen Deprivation Therapy
- ClinicalTrials.gov ID
- NCT06682390
- Acronym / sponsor ID
- 22-001730
- Conditions
- Prostate Cancer Metastatic Disease
- Keywords
- ADT, cardiovascular risk factors
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Comprehensive Cancer Network
- Study start
- 28 Mar 2024 (actual)
- Primary completion
- 20 Nov 2027 (estimated)
- Study completion
- 29 Nov 2027 (estimated)
- First posted
- 12 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
- 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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Hypocaloric anti-inflammatory dietParticipants will follow a hypocaloric anti-inflammatory diet for the last 3 months of the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- >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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypocaloric anti-inflammatory dietThe 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. | Behavioural | Hypocaloric anti-inflammatory diet |
Primary outcome
Fat mass
Time frame: At 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 circumference
Time frame: At 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.
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
- Individual participant dataSharing planned: No
Related trials for Prostate Cancer Metastatic Disease
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
RecruitingPhase 2
A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer
Metastatic Castration-Resistant Prostate Cancer
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingObservational study
ARCTIC: Liquid Biomarkers in the Prospective Androgen Receptor Signaling Inhibitors (ARSI) Resistance Clinical Trials
Prostate Cancer, Prostate Adenocarcinoma
Active, not recruitingPhase 2
FPI-2265 (225Ac-PSMA-I&T) and Olaparib for Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Metastatic Castration-resistant Prostate Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypocaloric anti-inflammatory diet in people with Prostate Cancer Metastatic Disease, run by University of California, Los Angeles at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tatiana Diacova, PhD, MS, RDN (310-825-8499, tdiacova@mednet.ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fat mass (time frame: At baseline, 3 months and 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2025; AzTrials last refreshed its copy on 8 Nov 2026.