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

Not Applicable

Completed

• Conditions: Prostate Cancer
• Interventions: Dietary Supplement: Olive Oil

• Registration Number: NCT01083771
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2009-02
• Study First Submitted: 2010-03-09
• Study First Submitted QC: 2010-03-09
• Study First Posted: 2010-03-10
• Primary Completion: 2010-09
• Study Completion: 2012-08
• Results First Submitted: 2015-06-09
• Results First Submitted QC: 2015-07-21
• Results First Posted: 2015-07-23
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-23
• Last Update Posted: 2022-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 21

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Olive Oil	Olive Oil	At least 3 tablespoons of olive oil each day

Primary Outcome Measures

Name	Time	Method
Changes in the Blood Chemistry (Fasting Triglycerides) After 8 Weeks of Following a Mediterranean Diet	eight weeks	Based on overall percentage change at baseline versus post diet

Secondary Outcome Measures

Name	Time	Method
To Assess Changes in the Body After 8 Weeks of Following a Mediterranean Diet	8 weeks	Post diet waist circumference

Trial Locations

Locations (1)

Miriam Hospital; 🇺🇸 Providence, Rhode Island, United States