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

NCT ID: NCT01083771

Last Updated: 2022-03-04

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2012-08-31

Brief Summary

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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

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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

Conditions

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Prostate Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Olive Oil

At least 3 tablespoons of olive oil each day

Group Type EXPERIMENTAL

Olive Oil

Intervention Type DIETARY_SUPPLEMENT

Minimum of 3 tablespoon of olive oil per day

Interventions

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Olive Oil

Minimum of 3 tablespoon of olive oil per day

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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The Miriam Hospital

OTHER

Sponsor Role collaborator

Brown University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anthony Mega, MD

Role: PRINCIPAL_INVESTIGATOR

The Miriam Hospital

Locations

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Miriam Hospital

Providence, Rhode Island, United States

Site Status

Countries

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United States

Other Identifiers

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BrUOG-MED/PROS-219

Identifier Type: -

Identifier Source: org_study_id

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