Metabolic Impact of Prospective Controlled Mediterranean Type Diets on Prostate Cancer

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Case Comprehensive Cancer Center
Study ID
NCT05590624
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Lower-Carbohydrate Med-t-Diet — OTHER
    Diet will focus on including: * Lean protein sources * High-quality fat * High-quality carbohydrate sources that are rich in fiber * Nuts and seeds Diet will focus on limiting: * Refined sugars * High glycemic carbohydrates * Seed oils that may cause inflammation Diet Composition: 45% fats, 35% carbs, 20% protein
  • Low-Fat Med-t-Diet — OTHER
    Diet will focus on including: * Lean protein sources * High-quality fat * High-quality carbohydrate sources that are rich in fiber * Nuts and seeds Diet will focus on limiting: * Refined sugars * High glycemic carbohydrates * Seed oils that may cause inflammation Diet Composition: 70% carbs, 20% protein, 10% fat

Study Details

The purpose of this study is to examine the impact of Mediterranean-type diets on the metabolism of men with localized prostate cancer. The optimal diet for men with a suspected diagnosis of Prostate Cancer (PCa) is currently unknown. More specifically, the suggested benefits of low carbohydrate and low fat diets in PCa are not determined.

Key Dates

Start date
Sep 3, 2024
Status verified
Feb 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

Arms

  • Experimental: Mediterranean-type Diet(s)-Arm 1
    Diet randomization occurs two weeks prior to the Standard of Care (SOC) diagnostic biopsy. If patient is randomized to Arm 1, they will receive Low Fat (LF) Mediterranean Diet first. The results of the diagnostic biopsy determines how the patient will proceed on the trial. If there is a confirmed Prostate Cancer (PCa) diagnosis AND is a candidate for Active Surveillance (AS) per SOC, then patient will undergo a washout period and cross-over to the Lower Carbohydrate (LC) Mediterranean Diet two weeks prior to the SOC confirmatory biopsy. A long-term follow-up (LTFU) visit will occur 3 months after the second dietary intervention has concluded. If patient does not have PCa or is not placed on AS, then they will only have the first dietary intervention and a LTFU visit 3 months after
  • Experimental: Mediterranean-type Diet(s)-Arm 2
    Diet randomization occurs two weeks prior to the Standard of Care (SOC) diagnostic biopsy. If patient is randomized to Arm 2, they will receive Lower Carbohydrate (LC) Mediterranean Diet first. The results of the diagnostic biopsy determines how the patient will proceed on the trial. If there is a confirmed Prostate Cancer (PCa) diagnosis AND is a candidate for Active Surveillance (AS) per SOC, then patient will undergo a washout period and cross-over to the Low Fat (LF) Mediterranean Diet two weeks prior to the SOC confirmatory biopsy. A long-term follow-up (LTFU) visit will occur 3 months after the second dietary intervention has concluded. If patient does not have PCa or is not placed on AS, then they will only have the first dietary intervention and a LTFU visit 3 months after.

Primary Outcome Measure

Evaluate the impact of Med-t-Diets on non-malignant prostate tissue metabolism [ Time Frame: Change from diagnostic biopsy (Week 2) at confirmatory biopsy ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Case Comprehensive Cancer Center, Cleveland Clinic FoundationClevelandOhio44195
Myra Krnac
[email protected]
216-444-1047

Find similar trials in Cleveland, OH

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Case Comprehensive Cancer Center, Cleveland Clinic Foundation· Cleveland, OH

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