N/A
Completed N=21
Med Diet Prevention Metabolic Syndrome Men Undergoing Androgen Deprivation Therapy Prostate Cancer
Source: ClinicalTrials.gov NCT01083771 ↗Enrolled (actual)
21
Serious AEs
4.8%
Results posted
Jul 2015
Primary outcomePrimary: Changes in the Blood Chemistry (Fasting Triglycerides) After 8 Weeks of Following a Mediterranean Diet — 21 percentage of change
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in the Blood Chemistry (Fasting Triglycerides) After 8 Weeks of Following a Mediterranean Diet |
21 | — |
| SECONDARY To Assess Changes in the Body After 8 Weeks of Following a Mediterranean Diet |
102.4 | — |
Eligibility Criteria
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 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
Data sourced from ClinicalTrials.gov (NCT01083771). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.