Trial Outcomes & Findings for The Impact of Pomegranate Extract on Chronic Cardiomyopathy Complicated by Renal Insufficiency (ImPrOVE): a Pilot Study (NCT NCT01102140)
NCT ID: NCT01102140
Last Updated: 2017-07-14
Results Overview
This is a serum marker of oxidative stress.
TERMINATED
PHASE2
20 participants
baseline and after 12 weeks
2017-07-14
Participant Flow
Participant milestones
| Measure |
POMx
The POMx subjects received 1000 mg of oral POMx for 12 weeks.
POMx, pomegranate polyphenol extract: 1000 mg orally once daily.
|
Control- Sugar Pill
The control subjects received a matching sugar pill for 12 weeks.
Sugar Pill: Matching sugar pill
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
7
|
|
Overall Study
COMPLETED
|
10
|
5
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
| Measure |
POMx
The POMx subjects received 1000 mg of oral POMx for 12 weeks.
POMx, pomegranate polyphenol extract: 1000 mg orally once daily.
|
Control- Sugar Pill
The control subjects received a matching sugar pill for 12 weeks.
Sugar Pill: Matching sugar pill
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Investigator terminated study
|
2
|
2
|
Baseline Characteristics
The Impact of Pomegranate Extract on Chronic Cardiomyopathy Complicated by Renal Insufficiency (ImPrOVE): a Pilot Study
Baseline characteristics by cohort
| Measure |
POMx
n=13 Participants
The POMx subjects received 1000 mg of oral POMx for 12 weeks.
POMx, pomegranate polyphenol extract: 1000 mg orally once daily.
|
Control- Sugar Pill
n=7 Participants
The control subjects received a matching sugar pill for 12 weeks.
Sugar Pill: Matching sugar pill
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
15 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
5 Participants
n=35 Participants
|
|
Age, Continuous
|
57 years
n=39 Participants
|
58 years
n=41 Participants
|
57 years
n=35 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
18 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=39 Participants
|
6 Participants
n=41 Participants
|
18 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=39 Participants
|
7 participants
n=41 Participants
|
20 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: baseline and after 12 weeksPopulation: Serum samples were obtained and frozen but never analyzed to obtain isoprostane values due to PI departure from study center prior to any batches being sent for analysis.
This is a serum marker of oxidative stress.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: Serum samples were obtained and frozen but never analyzed to obtain isoprostane values due to PI departure from study center prior to any batches being sent for analysis
This is a serum marker of oxidative stress.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline and 12 weeksPopulation: Serum samples were obtained and frozen but never analyzed to obtain procollagen values due to PI departure from study center prior to any batches being sent for analysis
This is a serum marker of collagen turnover (fibrosis/scar formation).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline and 12 weeksPopulation: Serum samples were obtained and frozen but never analyzed to obtain ADMA values due to PI departure from study center prior to any batches being sent for analysis
ADMA is a serum enzyme involved in metabolism of endothelium derived nitric oxide (NO). NO's has an important role in maintaining endothelial homeostasis. Elevated ADMA levels suggest impaired endothelial function.
Outcome measures
Outcome data not reported
Adverse Events
POMx
Control- Sugar Pill
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place