Trial Outcomes & Findings for Inflammation, Polyphenols, and Genetics (NCT NCT01568827)
NCT ID: NCT01568827
Last Updated: 2016-09-27
Results Overview
Area Under the time-concentration Curve (AUC) of IL-6
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
10 participants
Primary outcome timeframe
acute (0-12 hours) after inflammation-causing challenge meal
Results posted on
2016-09-27
Participant Flow
Participant milestones
| Measure |
Water First, Then Washout, Then Blackraspberry Slurry
8 oz. water daily x 5 days, 2 day washout, Blackraspberry slurry daily x 5 days
|
Blackraspberry Slurry First, Then Washout, Then Water
Blackraspberry slurry daily x 5 days, 2 day washout, 8 oz. water daily x 5 days
|
|---|---|---|
|
First Intervention (6 Days)
STARTED
|
5
|
5
|
|
First Intervention (6 Days)
COMPLETED
|
5
|
5
|
|
First Intervention (6 Days)
NOT COMPLETED
|
0
|
0
|
|
Washout (2 Days)
STARTED
|
5
|
5
|
|
Washout (2 Days)
COMPLETED
|
5
|
5
|
|
Washout (2 Days)
NOT COMPLETED
|
0
|
0
|
|
Intervention 2 (5 Days)
STARTED
|
5
|
5
|
|
Intervention 2 (5 Days)
COMPLETED
|
5
|
5
|
|
Intervention 2 (5 Days)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Inflammation, Polyphenols, and Genetics
Baseline characteristics by cohort
| Measure |
Black-raspberry Powder
n=5 Participants
Black-raspberry powder: Black-raspberry powder (45g) equivalent to about 450 g fresh black raspberries
|
No Intervention
n=5 Participants
Water without lypholized black raspberry powder
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.7 years
STANDARD_DEVIATION 6.9 • n=5 Participants
|
64.7 years
STANDARD_DEVIATION 6.9 • n=7 Participants
|
64.7 years
STANDARD_DEVIATION 6.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
10 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: acute (0-12 hours) after inflammation-causing challenge mealArea Under the time-concentration Curve (AUC) of IL-6
Outcome measures
| Measure |
Water
n=10 Participants
Water without lypholized black raspberry powder
|
Blackraspberry Slurry
n=10 Participants
Blackraspberry slurry: Black-raspberry powder (45g) equivalent to about 450 g fresh black raspberries mixed with 8 oz water
|
|---|---|---|
|
Serum IL-6
|
42.4 (pg*hr)/mL
Interval 24.5 to 60.3
|
34.3 (pg*hr)/mL
Interval 24.5 to 41.9
|
Adverse Events
Black-raspberry Slurry, Washout, Water
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Water, Washout, Black-raspberry Slurry
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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