Metabolic Impact and Compliance of Controlled, Varying, Mediterranean Diets in Pre-Surgical Prostate Cancer Populations (PROVISIONS)

Part of paid clinical trials in Miami, Florida.

Sponsor
University of Miami
Study ID
NCT06487507
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Low fat diet — BEHAVIORAL
    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 diet — BEHAVIORAL
    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 Details

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.

Key Dates

Start date
Apr 17, 2025
Status verified
Apr 2026
Primary completion
May 1, 2027
Completion
May 1, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Low Fat Diet Group
    Participants in this group will receive a low fat Mediterranean diet for 2 weeks.
  • Experimental: Lower Carbohydrate Mediterranean Diet Group
    Participants in this group will receive a lower carbohydrate Mediterranean diet for 2 weeks.

Primary Outcome Measure

Proportion of patients consuming Mediterranean diet [ Time Frame: Up to 2 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MiamiMiamiFlorida33136
Elena Cortizas, MS
[email protected]
3052433593
Nima Sharifi, MD (PRINCIPAL_INVESTIGATOR)
Sanoj Punnen, MD (SUB_INVESTIGATOR)

Find similar trials in Miami, FL

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
University of Miami· Miami, FL

Related Studies