Primary Objective To evaluate the gastric emptying time of the protein hydrolysates PRO+CHO beverage in patients with a delayed gastric emptying and compare this with the gastric emptying time of healthy subjects (PrePro1) Secondary Objectives To…
ID
Source
Brief title
Condition
- Malabsorption conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the gastric emptying time of CHO+PRO beverages in
patients with a delayed gastric emptying, calculated as the T1/2, Tlag and GEC
(gastric emptying coefficient) of the recovery of 13C from breath samples
measured continuously for 3 hours after ingestion.
T1/2 indicates the time by which half of the total cumulative recovery of the
13C label is attained, and Tlag designates the time at which the 13CO2
excretion rate reaches its maximal level; while GEC does not have a clear
definition, it is only generally used as an overall index of gastric emptying
Secondary outcome
Subjective compliance and preference parameters are measured by a
questionnaires. Bloodglucose will be monitored by executing a finger-stick
glucose test every hour in patients that are diabetic.
Background summary
Regarding optimization of preoperative nutrition with a PRO-CHO mixed beverage,
the Prepro1 study was conducted in which the time needed for a PRO+CHO
beverage, consisting of PeptoPro and Roosvicee, to pass through the stomach was
investigated. This study showed that the half-emptying time (t1/2) of the
stomach in healthy patients was around 80 minutes and it was recommended to
consume the beverage at least three hours before anaesthesia.
Since patients with a delayed gastric emptying time have higher risk for peri-
and postoperative complications it would be interesting to investigate the
gastric emptying time of the PRO-CHO mixed beverage in these patients as well.
This is done in the PrePro2 safety study where the interval between the intake
and operation is determined in order to diminish the chance of aspiration and
other complications.
Thus, in this study, the aim is to find out the time needed for the CHO+PRO
beverage to pass through the stomach in patients with a delayed gastric
emptying.
Study objective
Primary Objective
To evaluate the gastric emptying time of the protein hydrolysates PRO+CHO
beverage in patients with a delayed gastric emptying and compare this with the
gastric emptying time of healthy subjects (PrePro1)
Secondary Objectives
To find out participants* opinions on the palatability of the drink and their
compliance;
Study design
It will be an experimental study. The total duration of the study for each
participant will be 2 weeks. 1-2 weeks before starting the experiment, subjects
will be screened to check if they comply to the in- and exclusion criteria.
When positively screened, subjects can start participating in the experiment.
The experiment will be performed in duplo. The experimental trials will be
separated by a period of >7 days. Subjects are exposed to 400 ml water with
PRO+CHO.
Study burden and risks
There is no direct (health-related) benefit for the participant. Participants
can receive a summary of the results with averages of the group after the end
of the study.
The breath test measurements is non-invasive (breath test) and risks are
therefore minimal. The glucose test might be associated with a little pain as a
result of the finger prick.
Willy Brandtlaan 10
Ede 6716 RP
NL
Willy Brandtlaan 10
Ede 6716 RP
NL
Listed location countries
Age
Inclusion criteria
A proven delay in gastric emptying
Exclusion criteria
On a prescribed diet that interferes with the study fluids, allergic to milk protein
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL47844.081.14 |