Trial Outcomes & Findings for Effects of Pomegranate Extract on Intestinal Flora (NCT NCT02370641)
NCT ID: NCT02370641
Last Updated: 2019-10-02
Results Overview
Difference of percentage of total microflora between urolithin excretors and non-excretors after consumption of pomegranate extract for 4 weeks
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
26 participants
Primary outcome timeframe
4 weeks
Results posted on
2019-10-02
Participant Flow
The enrollment period was 10/31/2012 - 7/2/2013. Enrollment took place in a private setting in the clinic located at the site.
Twenty-six healthy participants were enrolled in the study. There were two study phases including a 2-week run-in period and a 4-week intervention period. Six subjects who did not complete the study were excluded.
Participant milestones
| Measure |
Urolithin Excretors
The excretor status was determined by analysis of urolithin A glucuronide in 24 hour urine after one dose of POMx. A blood sample and stool sample were obtained before administering the extract.
PomX: 1000 mg POMx daily for 4 weeks
|
Non Excretors
The excretor status was determined by the analysis of urolithin A glucuronide in 24 hour urine after one dose of POMx. A blood sample and stool sample were obtained before administering the extract.
PomX: 1000 mg POMx daily for 4 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
8
|
|
Overall Study
COMPLETED
|
14
|
6
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
Reasons for withdrawal
| Measure |
Urolithin Excretors
The excretor status was determined by analysis of urolithin A glucuronide in 24 hour urine after one dose of POMx. A blood sample and stool sample were obtained before administering the extract.
PomX: 1000 mg POMx daily for 4 weeks
|
Non Excretors
The excretor status was determined by the analysis of urolithin A glucuronide in 24 hour urine after one dose of POMx. A blood sample and stool sample were obtained before administering the extract.
PomX: 1000 mg POMx daily for 4 weeks
|
|---|---|---|
|
Overall Study
dropped study
|
4
|
2
|
Baseline Characteristics
Effects of Pomegranate Extract on Intestinal Flora
Baseline characteristics by cohort
| Measure |
Urolithin Excretors
n=14 Participants
The excretor status was determined by analysis of urolithin A glucuronide in 24 hour urine after one dose of POMx. A blood sample and stool sample were obtained before administering the extract.
PomX: 1000 mg POMx daily for 4 weeks
|
Non Excretors
n=6 Participants
The excretor status was determined by the analysis of urolithin A glucuronide in 24 hour urine after one dose of POMx. A blood sample and stool sample were obtained before administering the extract.
PomX: 1000 mg POMx daily for 4 weeks
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
white
|
12 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
23 kg/m^2
STANDARD_DEVIATION 3 • n=5 Participants
|
23 kg/m^2
STANDARD_DEVIATION 3 • n=7 Participants
|
23 kg/m^2
STANDARD_DEVIATION 3 • n=5 Participants
|
PRIMARY outcome
Timeframe: 4 weeksDifference of percentage of total microflora between urolithin excretors and non-excretors after consumption of pomegranate extract for 4 weeks
Outcome measures
| Measure |
Microbial Phylum Abundance in Urolithin Excretors
n=14 Participants
Microbial phylum abundance (% of total) in urolithin excretors after consumption of 1000 mg pomegranate extract daily for 4 weeks
|
Microbial Phylum Abundance in Non Excretors
n=6 Participants
Microbial phylum abundance (% of total) in urolithin excretors after consumption of 1000 mg pomegranate extract daily for 4 weeks.
|
|---|---|---|
|
Change in Percentage of Total Microflora Between Urolithin Excretors and Non-excretors
Percentage of phylum Firmecutes at baseline
|
60 percentage of total microflora
Standard Deviation 10.1
|
68 percentage of total microflora
Standard Deviation 17.2
|
|
Change in Percentage of Total Microflora Between Urolithin Excretors and Non-excretors
Percentage of phylum Firmecutes at week 4
|
56 percentage of total microflora
Standard Deviation 10.5
|
70 percentage of total microflora
Standard Deviation 9.3
|
|
Change in Percentage of Total Microflora Between Urolithin Excretors and Non-excretors
Percentage of phylum Proteobacteria at baseline
|
3.4 percentage of total microflora
Standard Deviation 2.5
|
2.5 percentage of total microflora
Standard Deviation 1.4
|
|
Change in Percentage of Total Microflora Between Urolithin Excretors and Non-excretors
Percentage of phylum Proteobacteria at week 4
|
6 percentage of total microflora
Standard Deviation 5.4
|
1.8 percentage of total microflora
Standard Deviation 0.5
|
Adverse Events
Microbial Phylum Abundance in Urolithin Excretors
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Microbial Phylum Abundance in Urolithin Non Excretors
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Microbial Phylum Abundance in Urolithin Excretors
n=14 participants at risk
microbial phylum abundance in urolithin excretors after consumption of 1000 mg pomegranate extract daily for 4 weeks
|
Microbial Phylum Abundance in Urolithin Non Excretors
n=6 participants at risk
The excretor status was determined by the analysis of urolithin A glucuronide in 24 hour urine after one dose of POMx. A blood sample and stool sample were obtained before administering the extract.
PomX: 1000 mg POMx daily for 4 weeks
|
|---|---|---|
|
Gastrointestinal disorders
nausea after taking supplement on empty stomach
|
7.1%
1/14 • Number of events 1 • Adverse event data was collected over a 4 week period
Participants were monitored and questioned regarding the occurrence and nature of any adverse experiences.
|
16.7%
1/6 • Number of events 1 • Adverse event data was collected over a 4 week period
Participants were monitored and questioned regarding the occurrence and nature of any adverse experiences.
|
|
Gastrointestinal disorders
mild gastrointestinal discomfort after taking supplement on empty stomach
|
7.1%
1/14 • Number of events 1 • Adverse event data was collected over a 4 week period
Participants were monitored and questioned regarding the occurrence and nature of any adverse experiences.
|
0.00%
0/6 • Adverse event data was collected over a 4 week period
Participants were monitored and questioned regarding the occurrence and nature of any adverse experiences.
|
Additional Information
Zhaoping Li, Professor
UCLA Department of Medicine/Center for Human Nutrition
Phone: 310-206-1987
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place