ClinicalTrials.Veeva

Menu

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

Brown University logo

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

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems