An interventional study of Olive Oil in Prostate Cancer, sponsored by Brown University. Completed at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-04.
Sponsored by Brown University · Not applicable, Interventional, and Prevention
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.
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
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 21 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Brown University is the lead sponsor of 282 studies on the registry; 42 are open to participants now.
Of its 25 completed or terminated interventional studies of FDA-regulated products, 18 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
At least 3 tablespoons of olive oil each day
Dietary Supplement: Olive Oil
Minimum of 3 tablespoon of olive oil per day
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
To Assess Changes in the Body After 8 Weeks of Following a Mediterranean Diet
Post diet waist circumference
Time frame: 8 weeks
| Milestone | Olive Oil |
|---|---|
| Started | 21 |
| Completed | 16 |
| Not completed | 5 |
| Withdrew: Non-compliant | 2 |
| Withdrew: Withdrawal by subject | 3 |
Based on overall percentage change at baseline versus post diet
| percentage of change | Olive Oil |
|---|---|
| Changes in the Blood Chemistry (Fasting Triglycerides) After 8 Weeks of Following a Mediterranean Diet | 21 ± 38.2 |
Post diet waist circumference
| centimeters | Olive Oil |
|---|---|
| To Assess Changes in the Body After 8 Weeks of Following a Mediterranean Diet | 102.4 ± 8.8 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Olive Oil | — | 1/21 (4.8%) | 1/21 (4.8%) |
| Event | Olive Oil |
|---|---|
| Chest painCardiac disorders | 1/21 |
| Event | Olive Oil |
|---|---|
| creatinine increasedBlood and lymphatic system disorders | 1/21 |
| Age, Categorical(Participants) | Olive Oil |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 10 |
| >=65 years | 11 |
| Age, Continuous(years) | Olive Oil |
|---|---|
| Mean | 69.9 (58 to 80) |
| Sex: Female, Male(Participants) | Olive Oil |
|---|---|
| Female | 0 |
| Male | 21 |
| Region of Enrollment(participants) | Olive Oil |
|---|---|
| United States | 21 |
This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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