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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: N/A
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

Resource links provided by the National Library of Medicine

Drug Information available for: Olive oil

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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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United States, Rhode Island
Miriam Hospital
Providence, Rhode Island, United States, 02906
Sponsors and Collaborators
Dr Anthony Mega
The Miriam Hospital
Investigators
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Principal Investigator: Anthony Mega, MD The Miriam Hospital
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Responsible Party: Dr Anthony Mega, Principal Investigator, Brown University
ClinicalTrials.gov Identifier: NCT01083771    
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:
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Prostatic Neoplasms
Metabolic Syndrome
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases