Trial Outcomes & Findings for Med Diet Prevention Metabolic Syndrome Men Undergoing Androgen Deprivation Therapy Prostate Cancer (NCT NCT01083771)

Results Overview

Based on overall percentage change at baseline versus post diet

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

21 participants

Primary outcome timeframe

eight weeks

Results posted on

2022-03-04

Participant milestones
Measure	Olive Oil At least 3 tablespoons of olive oil each day Olive Oil: Minimum of 3 tablespoon of olive oil per day
Overall Study STARTED	21
Overall Study COMPLETED	16
Overall Study NOT COMPLETED	5

Reasons for withdrawal
Measure	Olive Oil At least 3 tablespoons of olive oil each day Olive Oil: Minimum of 3 tablespoon of olive oil per day
Overall Study non-compliant	2
Overall Study Withdrawal by Subject	3

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

Baseline characteristics by cohort
Measure	Olive Oil n=21 Participants At least 3 tablespoons of olive oil each day Olive Oil: Minimum of 3 tablespoon of olive oil per day
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants
Age, Categorical >=65 years	11 Participants n=5 Participants
Age, Continuous	69.9 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants
Region of Enrollment United States	21 participants n=5 Participants

Timeframe: eight weeks

Based on overall percentage change at baseline versus post diet

Outcome measures
Measure	Olive Oil n=21 Participants At least 3 tablespoons of olive oil each day 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	21 percentage of change Standard Deviation 38.2

Timeframe: 8 weeks

Post diet waist circumference

Outcome measures
Measure	Olive Oil n=21 Participants At least 3 tablespoons of olive oil each day Olive Oil: Minimum of 3 tablespoon of olive oil per day
To Assess Changes in the Body After 8 Weeks of Following a Mediterranean Diet	102.4 centimeters Standard Deviation 8.8

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events
Measure	Olive Oil n=21 participants at risk At least 3 tablespoons of olive oil each day Olive Oil: Minimum of 3 tablespoon of olive oil per day
Cardiac disorders Chest pain	4.8% 1/21 • Number of events 1

Other adverse events
Measure	Olive Oil n=21 participants at risk At least 3 tablespoons of olive oil each day Olive Oil: Minimum of 3 tablespoon of olive oil per day
Blood and lymphatic system disorders creatinine increased	4.8% 1/21 • Number of events 1

Brown University Oncology Research Group (BrUOG)

Phone: 4018633000