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

This study has been completed.
Sponsor:
Collaborator:
The Miriam Hospital
Information provided by (Responsible Party):
Dr Anthony Mega, Brown University
ClinicalTrials.gov Identifier:
NCT01083771
First received: March 9, 2010
Last updated: April 9, 2013
Last verified: June 2012
  Purpose

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 Intervention
Prostate Cancer
Dietary Supplement: Olive Oil

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Brown University:

Primary Outcome Measures:
  • To assess changes in the blood chemistry levels after 8 weeks of following a Mediterranean diet [ Time Frame: eight weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess changes in the af body weight after 8 weeks of following a Mediterranean diet [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 21
Study Start Date: February 2009
Study Completion Date: August 2012
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Dr Anthony Mega, Principal Investigator, Brown University
ClinicalTrials.gov Identifier: NCT01083771     History of Changes
Other Study ID Numbers: BrUOG-MED/PROS-219
Study First Received: March 9, 2010
Last Updated: April 9, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 20, 2014