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

• Sponsor: Brown University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01083771
• Collaborator: The Miriam Hospital (Other)
• Enrollment: 21
• Location: 1
• Arm: 1
• Duration (Months): 42
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Dietary Supplement: Olive Oil	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 21 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official 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
• Study Start Date: Feb 1, 2009
• Actual Primary Completion Date: Sep 1, 2010
• Actual Study Completion Date: Aug 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Olive Oil At least 3 tablespoons of olive oil each day	Dietary Supplement: Olive Oil; Minimum of 3 tablespoon of olive oil per day

Outcome Measures

Primary Outcome Measures

1. 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

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

   Post diet waist circumference

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Miriam Hospital	Providence	Rhode Island	United States	02906

Sponsors and Collaborators

• Brown University
• The Miriam Hospital

Investigators

• Principal Investigator: Anthony Mega, MD, The Miriam Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Brown University
• ClinicalTrials.gov Identifier: NCT01083771
• Other Study ID Numbers: BrUOG-MED/PROS-219
• First Posted: Mar 10, 2010
• Last Update Posted: Mar 4, 2022
• Last Verified: Feb 1, 2022

• Additional relevant MeSH terms: Prostatic Neoplasms; Metabolic Syndrome

Study Results

Participant Flow

Arm/Group Title	Olive Oil
Arm/Group Description	At least 3 tablespoons of olive oil each day Olive Oil: Minimum of 3 tablespoon of olive oil per day
Period Title: Overall Study
STARTED	21
COMPLETED	16
NOT COMPLETED	5

Baseline Characteristics

Arm/Group Title	Olive Oil
Arm/Group Description	At least 3 tablespoons of olive oil each day Olive Oil: Minimum of 3 tablespoon of olive oil per day
Overall Participants	21
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	10 47.6%
>=65 years	11 52.4%
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	69.9
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	21 100%
Region of Enrollment (participants) [Number]
United States	21 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Olive Oil
Arm/Group Description	At least 3 tablespoons of olive oil each day Olive Oil: Minimum of 3 tablespoon of olive oil per day
Measure Participants	21
Mean (Standard Deviation) [percentage of change]	21 (38.2)

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Olive Oil
Arm/Group Description	At least 3 tablespoons of olive oil each day Olive Oil: Minimum of 3 tablespoon of olive oil per day
Measure Participants	21
Mean (Standard Deviation) [centimeters]	102.4 (8.8)

Adverse Events

Arm/Group Title	Olive Oil
Arm/Group Description	At least 3 tablespoons of olive oil each day Olive Oil: Minimum of 3 tablespoon of olive oil per day
All Cause Mortality
	Olive Oil
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Olive Oil
	Affected / at Risk (%)	# Events
Total	1/21 (4.8%)
Cardiac disorders
Chest pain	1/21 (4.8%)	1
Other (Not Including Serious) Adverse Events
	Olive Oil
	Affected / at Risk (%)	# Events
Total	1/21 (4.8%)
Blood and lymphatic system disorders
creatinine increased	1/21 (4.8%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.