Prostate Cancer
Conditions
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.
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
Interventions
DIETARY_SUPPLEMENTOlive Oil
Minimum of 3 tablespoon of olive oil per day
Sponsors
The Miriam Hospital
Brown University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
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 \>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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| To Assess Changes in the Body After 8 Weeks of Following a Mediterranean Diet | 8 weeks | Post diet waist circumference |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Olive Oil At least 3 tablespoons of olive oil each day
Olive Oil: Minimum of 3 tablespoon of olive oil per day | 21 |
| Total | 21 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | non-compliant | 2 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | Olive Oil |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 11 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants |
| Age, Continuous | 69.9 years |
| Region of Enrollment United States | 21 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1 / 21 |
| serious Total, serious adverse events | 1 / 21 |
Outcome results
Primary
Changes in the Blood Chemistry (Fasting Triglycerides) After 8 Weeks of Following a Mediterranean Diet
Based on overall percentage change at baseline versus post diet
Time frame: eight weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Olive Oil | Changes in the Blood Chemistry (Fasting Triglycerides) After 8 Weeks of Following a Mediterranean Diet | 21 percentage of change | Standard Deviation 38.2 |
Secondary
To Assess Changes in the Body After 8 Weeks of Following a Mediterranean Diet
Post diet waist circumference
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Olive Oil | To Assess Changes in the Body After 8 Weeks of Following a Mediterranean Diet | 102.4 centimeters | Standard Deviation 8.8 |