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Completed

NCT Number: NCT01083771

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

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Miriam Hospital

Providence, Rhode Island, 02906, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Olive Oil

Dietary Supplement

Minimum of 3 tablespoon of olive oil per day

Primary outcomes

  1. Changes in the Blood Chemistry (Fasting Triglycerides) After 8 Weeks of Following a Mediterranean Diet

    Time frame: eight weeks

    Based on overall percentage change at baseline versus post diet

Secondary outcomes

  1. To Assess Changes in the Body After 8 Weeks of Following a Mediterranean Diet

    Time frame: 8 weeks

    Post diet waist circumference

Sponsors and collaborators

Lead sponsor

Brown University

Other

Collaborators

  • The Miriam Hospital

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2010
Study completion
2012
First posted
Mar 10, 2010
Registry last updated
Mar 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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