The primary objective is twofold; first to get information on the between subject variation in gastric emptying to make between group comparisons (young adults vs. elderly). Second, to obtain information on the within subject variation of gastric…
ID
Source
Brief title
Condition
- Appetite and general nutritional disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study outcome is gastric emptying (and the variation in that
measurement). Gastric emptying will be measured with a non-invasive breath
test. The subject will come in fasting state to the research centre and ingest
the test product which is labelled with 13C. The test foods consist of 2
experimental cooked foods, differing in energy content. Each food will be
measured in duplicate. Breath samples will be collected before consumption of
the food and at 15 minute intervals during 4-6 hours. Breath samples will be
analyzed on concentration of 13C. 13C recovery (T1/2 and Tlag) will be used as
a measure for gastric emptying.
Secondary outcome
Secondary, appetite and wellbeing ratings will be measured during the test
(Visual Analogue Scales).
Background summary
Meal termination is mainly caused by the volume of food via stretch receptors
in the stomach. It might be that in older people gastric distension is
increased due to gastroparesis and/or delayed gastric emptying. This may lead
to smaller meals and eventually in anorexia of ageing.
By means of this pilot we aim to set up a non-invasive method to measure
gastric emptying, and more important, we are getting information on the within
and between subject variation of this measurement. For future research
purposes, we are especially interested in the effects of ageing and the effects
of certain foods or meals.
Study objective
The primary objective is twofold; first to get information on the between
subject variation in gastric emptying to make between group comparisons (young
adults vs. elderly). Second, to obtain information on the within subject
variation of gastric emptying to make within subject comparisons (low vs. high
energy content).
Study design
Observational study with 4 gastric emptying measurements per subject and 2
study groups.
Study burden and risks
Subjects will have to come 4 times to the research centre to undergo the breath
test (4-6 hours). Prior to participation subjects will have a screening visit
of ca. 15 minutes (inclusion questionnaire; measurement of weight and height;
explanation of the procedure).
The study is non-therapeutic to the participant. The risk associated with
participation is negligible. Compared to other studies, the burden can be
considered as low. No invasive measurements are present.
Postbus 8129
6703 HD Wageningen
Nederland
Postbus 8129
6703 HD Wageningen
Nederland
Listed location countries
Age
Inclusion criteria
Apparently healthy, as judged by the subject
Age: Young adults: 18-30 year, Older adults: 60-80 year
Used to eating breakfast (> 5 times per week)
Exclusion criteria
Weight change of >5kg during the last 2 months
Being on a weight loss diet
On a prescribed diet that interferes with the study foods
Bowel or stomach disorder
Diabetes or thyroid disorder
Food intolerance or allergy for foods that are provided during the study
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 | NL19415.081.07 |