Med Diet Prevention Metabolic Syndrome Men Undergoing Androgen Deprivation Therapy Prostate Cancer
Eight Week Plant-based Mediterranean Diet as Prevention of Metabolic Syndrome in Men Undergoing Androgen Deprivation Therapy for Prostate Cancer: A BrUOG Pilot Study
1 other identifier
interventional
21
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable prostate-cancer
Started Feb 2009
Typical duration for not_applicable prostate-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2009
CompletedFirst Submitted
Initial submission to the registry
March 9, 2010
CompletedFirst Posted
Study publicly available on registry
March 10, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedResults Posted
Study results publicly available
July 23, 2015
CompletedMarch 4, 2022
February 1, 2022
1.6 years
March 9, 2010
June 9, 2015
February 23, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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
eight weeks
Secondary Outcomes (1)
To Assess Changes in the Body After 8 Weeks of Following a Mediterranean Diet
8 weeks
Study Arms (1)
Olive Oil
EXPERIMENTALAt least 3 tablespoons of olive oil each day
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Brown Universitylead
- The Miriam Hospitalcollaborator
Study Sites (1)
Miriam Hospital
Providence, Rhode Island, 02906, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Anthony Mega, MD
- Organization
- Brown University Oncology Research Group (BrUOG)
Study Officials
- PRINCIPAL INVESTIGATOR
Anthony Mega, MD
The Miriam Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 9, 2010
First Posted
March 10, 2010
Study Start
February 1, 2009
Primary Completion
September 1, 2010
Study Completion
August 1, 2012
Last Updated
March 4, 2022
Results First Posted
July 23, 2015
Record last verified: 2022-02