Prostate CancerNCT06487507
Metabolic Impact and Compliance of Controlled, Varying, Mediterranean Diets in Pre-Surgical Prostate Cancer Populations (PROVISIONS)
A study testing Low fat diet and Lower carbohydrate diet in people with Prostate Cancer, run by University of Miami at 1 site in United States.
Trial summary
The study aims to investigate whether following a controlled Mediterranean-style diet prior to robotic-assisted radical prostatectomy surgery in patients diagnosed with prostate cancer affects fasting insulin levels and other values that can be measured in blood and tissue samples from surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Low fat diet and Lower carbohydrate diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Apr 2025to 1 May 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 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males 18 to 80 years old scheduled to undergo radical prostatectomy as per standard of care.
- BMI between 18.5 and 40
- Ability to read, write, speak, and understand English and/or Spanish.
- Ability to provide informed consent.
- Willingness to consume provided dietary interventions.
- Adequate organ and marrow function as assessed by treating clinician(s) which includes: White blood cell count (WBC) ≥2,500/microliter. Absolute neutrophil count (ANC) ≥1,500/microliter. Platelets ≥100,000/microliter. Hemoglobin ≥9 g/dL (transfusions permitted) Total bilirubin ≤1.5 x the institutional upper limit of normal (ULN). For subjects with Gilbert's disease ≤3.0 mg/dL. Aspartate aminotransferase (AST)/Alanine aminotransferase (ALT) ≤2.5 x institutional ULN. Creatinine clearance ≥51 ml/min as defined by Cockcroft-Gault equation.
Who cannot join
- Currently consuming a Mediterranean, lower carbohydrate, ketogenic, vegan, vegetarian, high fiber diet (14g fiber > per 1,000 Calories) and/or any supplements (including herbal), vitamins, minerals, that would interfere with diets being tested in the study as determined by dietitian and/or investigators as these diets are highly restrictive and may impact objectives/outcomes in the trial.
- Previous intolerability to fiber-rich diets.
- Colitis, Irritable Bowel Syndrome, or other gastrointestinal condition per clinician discretion.
- Food allergies or other major dietary restrictions.
- Receiving active medical treatment for Type I or Type II diabetes mellitus.
- Recent weight loss or gain (both intentional and unintentional) as defined by 5%+ body weight in the last 30 days.
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- Undergone any type of weight loss surgery.
- Any medical contraindications as determined by investigators.
- History of diabetic ketoacidosis.
- History of Gout.
- Patients that are immunosuppressed (transplant history, on immunosuppression, etc.) as per clinician discretion.
- Gallbladder removed or plan to remove per clinician evaluation.
- Other malignancies actively receiving systemic treatment as per clinician evaluation.
- Previous treatment for prostate cancer.
- Previous history of pelvic radiation.
- Patients with impaired decision-making capacity.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Miami
Miami, Florida, 33136
Elena Cortizas, MS, 3052433593, ecortizas@med.miami.edu
Nima Sharifi, MD
About this study
The study aims to investigate whether following a controlled Mediterranean-style diet prior to robotic-assisted radical prostatectomy surgery in patients diagnosed with prostate cancer affects fasting insulin levels and other values that can be measured in blood and tissue samples from surgery.
- Conditions
- Prostate Cancer
- Being tested
- Low fat diet, Lower carbohydrate diet
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low fat dietBehavioural
Prior to surgery, participants complete diet records for 7 days. After, participants will receive one shipment containing prepared meals (refrigerated, frozen and fresh) low fat Mediterranean that will be tested on this trial. The dietary intervention will be followed daily for two (2) weeks. Participants will complete a food frequency questionnaire to track food consumption. The diet will focus on including lean protein sources, high-quality fat and high-quality carbohydrate sources among others, and will limit refined sugars and high glycemic carbohydrates.
Lower carbohydrate dietBehavioural
Prior to surgery, participants complete diet records for 7 days. After, participants will receive one shipment containing prepared meals (refrigerated, frozen and fresh) lower carbohydrate Mediterranean that will be tested on this trial. The dietary intervention will be followed daily for two (2) weeks. Participants will complete a food frequency questionnaire to track food consumption. The diet will focus on including lean protein sources, high-quality fat and high-quality carbohydrate sources among others, and will limit refined sugars and high glycemic carbohydrates.
| Study group | Role | What they receive |
|---|---|---|
| Low Fat Diet Group | Experimental | Participants in this group will receive a low fat Mediterranean diet for 2 weeks. Receives: Behavioral: Low fat diet |
| Lower Carbohydrate Mediterranean Diet Group | Experimental | Participants in this group will receive a lower carbohydrate Mediterranean diet for 2 weeks. Receives: Behavioral: Lower carbohydrate diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients consuming Mediterranean diet
Defined as the proportion of patients who consumed greater than 80% of provided calories using diet records.
Measured: Up to 2 weeks
Secondary outcomes (6)
Change in fasting insulin
Measured in milliliters
Measured: Baseline to 2 weeks
Change in high-sensitivity c-reactive protein
Measured in milligrams per liter
Measured: Baseline to 2 weeks
Change in fasting glucose
Measured in milligrams per deciliter
Measured: Baseline to 2 weeks
Change in blood pressure
Measured in millimeters of mercury
Measured: Baseline to 2 weeks
Dietary behavior as measured by diet records questionnaire
Measured in percentage of meals consumed by the participants
Measured: Up to 2 weeks
Number of treatment related adverse events
Measured by fewer than three grade 3 adverse events using the NCI CTCAE version 6.0.
Measured: Up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start17 Apr 2025
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of MiamiThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nima Sharifi, University of Miami
- Investigators
- Nima Sharifi, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06487507
- Sponsor's protocol ID
- 20240052
- Status last verified
- Apr 2026
- First submitted
- 27 Jun 2024
- Last updated
- 23 Apr 2026
- 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 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Impact and Compliance of Controlled, Varying, Mediterranean Diets in Pre-Surgical Prostate Cancer Populations (PROVISIONS)
- ClinicalTrials.gov ID
- NCT06487507
- Acronym / sponsor ID
- 20240052
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 17 Apr 2025 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 5 Jul 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.
The study aims to investigate whether following a controlled Mediterranean-style diet prior to robotic-assisted radical prostatectomy surgery in patients diagnosed with prostate cancer affects fasting insulin levels and other values that can be measured in blood and tissue samples from surgery.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Fat Diet Group | Experimental | Behavioral: Low fat dietParticipants in this group will receive a low fat Mediterranean diet for 2 weeks. |
| Lower Carbohydrate Mediterranean Diet Group | Experimental | Behavioral: Lower carbohydrate dietParticipants in this group will receive a lower carbohydrate Mediterranean diet for 2 weeks. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Males 18 to 80 years old scheduled to undergo radical prostatectomy as per standard of care.
- BMI between 18.5 and 40
- Ability to read, write, speak, and understand English and/or Spanish.
- Ability to provide informed consent.
- Willingness to consume provided dietary interventions.
Key exclusion criteria (16 listed)
- Currently consuming a Mediterranean, lower carbohydrate, ketogenic, vegan, vegetarian, high fiber diet (14g fiber > per 1,000 Calories) and/or any supplements (including herbal), vitamins, minerals, that would interfere with diets being tested in the study as determined by dietitian and/or investigators as these diets are highly restrictive and may impact objectives/outcomes in the trial.
- Previous intolerability to fiber-rich diets.
- Colitis, Irritable Bowel Syndrome, or other gastrointestinal condition per clinician discretion.
- Food allergies or other major dietary restrictions.
- Receiving active medical treatment for Type I or Type II diabetes mellitus.
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 |
|---|---|---|
| Low fat dietPrior to surgery, participants complete diet records for 7 days. After, participants will receive one shipment containing prepared meals (refrigerated, frozen and fresh) low fat Mediterranean that will be tested on this trial. The dietary intervention will be followed daily for two (2) weeks. Participants will complete a food frequency questionnaire to track food consumption. The diet will focus on including lean protein sources, high-quality fat and high-quality carbohydrate sources among others, and will limit refined sugars and high glycemic carbohydrates. | Behavioural | Low Fat Diet Group |
| Lower carbohydrate dietPrior to surgery, participants complete diet records for 7 days. After, participants will receive one shipment containing prepared meals (refrigerated, frozen and fresh) lower carbohydrate Mediterranean that will be tested on this trial. The dietary intervention will be followed daily for two (2) weeks. Participants will complete a food frequency questionnaire to track food consumption. The diet will focus on including lean protein sources, high-quality fat and high-quality carbohydrate sources among others, and will limit refined sugars and high glycemic carbohydrates. | Behavioural | Lower Carbohydrate Mediterranean Diet Group |
Primary outcome
Proportion of patients consuming Mediterranean diet
Time frame: Up to 2 weeks
Defined as the proportion of patients who consumed greater than 80% of provided calories using diet records.
6 secondary outcomes
Change in fasting insulin
Time frame: Baseline to 2 weeks
Change in high-sensitivity c-reactive protein
Time frame: Baseline to 2 weeks
Change in fasting glucose
Time frame: Baseline to 2 weeks
Change in blood pressure
Time frame: Baseline to 2 weeks
Dietary behavior as measured by diet records questionnaire
Time frame: Up to 2 weeks
Number of treatment related adverse events
Time frame: Up to 2 weeks
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 23 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Nima Sharifi, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low fat diet and Lower carbohydrate diet in people with Prostate Cancer, run by University of Miami at 1 site 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 6 inclusion and 16 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 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Nima Sharifi, MD (305-243-1350, nimasharifi@miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients consuming Mediterranean diet (time frame: Up to 2 weeks). 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 23 Apr 2026.