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

Brown University

Status: Completed

Conditions: Prostate Cancer

Treatments: Dietary Supplement: Olive Oil

Study type: Interventional

Funder types: Other

Identifiers

NCT01083771

BrUOG-MED/PROS-219

Details and patient eligibility

About

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.

Full 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

Enrollment: 21 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

21 participants in 1 patient group

Olive Oil

Experimental group

Description:

At least 3 tablespoons of olive oil each day

Treatment:

Dietary Supplement: Olive Oil