Trial Outcomes & Findings for Gastric pH and Anthocyanin Absorption (NCT NCT01122160)
NCT ID: NCT01122160
Last Updated: 2013-08-23
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
13 participants
Primary outcome timeframe
1 hour prior to gastric emptying on Day 7 of the given intervention
Results posted on
2013-08-23
Participant Flow
Discrepancy between actual enrollment and number of participants in participant flow module is due to enrolled participants no longer meeting exclusion criteria (i.e., inability to swallow capsule).
Participant milestones
| Measure |
Placebo First, Then Omeprazole
Placebo with berries (blackberries + strawberries), followed by Omeprazole with berries (blackberries + strawberries)
|
Omeprazole First, Then Placebo
Prilosec (omeprazole) 20.6 mg tablet with berries (blackberries + strawberries), followed by placebo with berries (blackberries + strawberries)
|
|---|---|---|
|
First Intervention (7 Days)
STARTED
|
6
|
5
|
|
First Intervention (7 Days)
COMPLETED
|
6
|
5
|
|
First Intervention (7 Days)
NOT COMPLETED
|
0
|
0
|
|
Washout (7-14 Days)
STARTED
|
6
|
5
|
|
Washout (7-14 Days)
COMPLETED
|
6
|
5
|
|
Washout (7-14 Days)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (7 Days)
STARTED
|
6
|
5
|
|
Second Intervention (7 Days)
COMPLETED
|
6
|
5
|
|
Second Intervention (7 Days)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Gastric pH and Anthocyanin Absorption
Baseline characteristics by cohort
| Measure |
All Study Participants
n=11 Participants
All participants received both interventions.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
|
Age Continuous
|
35 years
STANDARD_DEVIATION 13.8 • n=93 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 1 hour prior to gastric emptying on Day 7 of the given interventionOutcome measures
| Measure |
Experimental
n=11 Participants
|
Placebo
n=11 Participants
|
|---|---|---|
|
Gastric pH
|
0.96 pH
Standard Deviation 0.37
|
2.31 pH
Standard Deviation 0.63
|
Adverse Events
Experimental
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
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