Back to resultsMed Diet Prevention Metabolic Syndrome Men Undergoing Androgen Deprivation Therapy Prostate Cancer
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Olive Oil
Sponsored by
About this trial
This is an interventional prevention trial for Prostate Cancer
Eligibility 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
Sites / Locations
- Miriam Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Olive Oil
Arm Description
At least 3 tablespoons of olive oil each day
Outcomes
Primary Outcome Measures
Changes in the Blood Chemistry (Fasting Triglycerides) After 8 Weeks of Following a Mediterranean Diet
Based on overall percentage change at baseline versus post diet
Secondary Outcome Measures
To Assess Changes in the Body After 8 Weeks of Following a Mediterranean Diet
Post diet waist circumference
Full Information
NCT ID
NCT01083771
First Posted
March 9, 2010
Last Updated
February 23, 2022
Sponsor
Brown University
Collaborators
The Miriam Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01083771
Brief Title
Med Diet Prevention Metabolic Syndrome Men Undergoing Androgen Deprivation Therapy Prostate Cancer
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 Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
August 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Brown University
Collaborators
The Miriam Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Olive Oil
Arm Type
Experimental
Arm Description
At least 3 tablespoons of olive oil each day
Intervention Type
Dietary Supplement
Intervention Name(s)
Olive Oil
Intervention Description
Minimum of 3 tablespoon of olive oil per day
Primary Outcome Measure Information:
Title
Changes in the Blood Chemistry (Fasting Triglycerides) After 8 Weeks of Following a Mediterranean Diet
Description
Based on overall percentage change at baseline versus post diet
Time Frame
eight weeks
Secondary Outcome Measure Information:
Title
To Assess Changes in the Body After 8 Weeks of Following a Mediterranean Diet
Description
Post diet waist circumference
Time Frame
8 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony Mega, MD
Organizational Affiliation
The Miriam Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Miriam Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Med Diet Prevention Metabolic Syndrome Men Undergoing Androgen Deprivation Therapy Prostate Cancer
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