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Eight Week Plant-based Mediterranean Diet as Prevention of Metabolic Syndrome in Men Undergoing Androgen Deprivation Therapy for Prostate Cancer: A BrUOG Pilot Study


N/A
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

Eight Week Plant-based Mediterranean Diet as Prevention of Metabolic Syndrome in Men Undergoing Androgen Deprivation Therapy for Prostate Cancer: A BrUOG Pilot Study


Primary Objective: To assess for changes in the following measurements after 8 weeks of
following a Mediterranean diet-- LDL, HDL, TG, FBS, creatinine, serum testosterone,
triglycerides, serum insulin, CRP, 1bs, Waist circumference, blood pressure, body weight


Inclusion Criteria:



- Histologically documented carcinoma of the prostate

- On treatment with androgen deprivation therapy for at least 3 months

- Required laboratory values:

- Serum creatinine less than 2.5

- Triglycerides <300

- Fasting glucose < 126

- Testosterone level <50

Exclusion Criteria:

- No diabetes mellitus (Type 1 or 2)

- No renal failure (Serum creatinine > 2.5)

- No active cardiac disease -no history of myocardial infarction/stroke within the last
12 months, no recurrent unstable angina, uncontrolled/unstable arrhythmias,
uncontrolled hypertension (systolic blood pressure >160, diastolic blood pressure
>100)

- No severe peripheral vascular disease

- No commencement of lipid lowering agent within 8 weeks of enrollment the study or
change in dose throughout the study

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

To assess changes in the blood chemistry levels after 8 weeks of following a Mediterranean diet

Outcome Time Frame:

eight weeks

Safety Issue:

No

Principal Investigator

Anthony Mega, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Miriam Hospital

Authority:

United States: Institutional Review Board

Study ID:

BrUOG-MED/PROS-219

NCT ID:

NCT01083771

Start Date:

February 2009

Completion Date:

August 2012

Related Keywords:

  • Prostate Cancer
  • Prostatic Neoplasms
  • Metabolic Syndrome X

Name

Location
Miriam Hospital Providence, Rhode Island  02906