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Med Diet Prevention Metabolic Syndrome Men Undergoing Androgen Deprivation Therapy Prostate Cancer

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ClinicalTrials.gov Identifier: NCT01083771
Recruitment Status : Completed
First Posted : March 10, 2010
Results First Posted : July 23, 2015
Last Update Posted : July 23, 2015
Sponsor:
Collaborator:
The Miriam Hospital
Information provided by (Responsible Party):
Dr Anthony Mega, Brown University

Brief Summary:
The purpose of this study is to assess for changes in a patient's overall energy level and well-being (quality of life) after 8 weeks of dietary intervention.

Condition or disease Intervention/treatment Phase
Prostate Cancer Dietary Supplement: Olive Oil Not Applicable

Detailed Description:
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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Eight Week Plant-based Mediterranean Diet as Prevention of Metabolic Syndrome in Men Undergoing Androgen Deprivation Therapy for Prostate Cancer: A BrUOG Pilot Study
Study Start Date : February 2009
Actual Primary Completion Date : September 2010
Actual Study Completion Date : August 2012


Arm Intervention/treatment
Experimental: Olive Oil
At least 3 tablespoons of olive oil each day
Dietary Supplement: Olive Oil
Minimum of 3 tablespoon of olive oil per day



Primary Outcome Measures :
  1. Changes in the Blood Chemistry (Fasting Triglycerides) After 8 Weeks of Following a Mediterranean Diet [ Time Frame: eight weeks ]
    Based on overall percentage change at baseline versus post diet


Secondary Outcome Measures :
  1. To Assess Changes in the Body After 8 Weeks of Following a Mediterranean Diet [ Time Frame: 8 weeks ]
    Post diet waist circumference



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01083771


Locations
United States, Rhode Island
Miriam Hospital
Providence, Rhode Island, United States, 02906
Sponsors and Collaborators
Dr Anthony Mega
The Miriam Hospital
Investigators
Principal Investigator: Anthony Mega, MD The Miriam Hospital

Responsible Party: Dr Anthony Mega, Principal Investigator, Brown University
ClinicalTrials.gov Identifier: NCT01083771     History of Changes
Other Study ID Numbers: BrUOG-MED/PROS-219
First Posted: March 10, 2010    Key Record Dates
Results First Posted: July 23, 2015
Last Update Posted: July 23, 2015
Last Verified: July 2015

Additional relevant MeSH terms:
Prostatic Neoplasms
Metabolic Syndrome X
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs