To implement the 13C breath test for measuring gastric emptying rate in healthy volunteers at NIZO food research. To obtain insight in variation of measures of gastric emptying for specific model foods.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
normale processen van vertering en absorptie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Gastric emptying rate, based on 13CO2/12CO2 ratio in expired breath for up to 3
hours after meal consumption, and expressed as half-emptying time and lag
phase.
Secondary outcome
Other gastric emptying parameters:
Gastric Emptying Coefficient
Percentage Dose Recovery (PDR)
Cumulative PDR
Glucose concentration in finger prick blood
Background summary
Rate of gastric emptying is an important determinant of postprandial nutrient
absorption and subsequent physiological processes. Food structure may affect
gastric emptying rate, which may be measured by the 13C breath test. However,
food structure may also affect the validity of the breath test. NIZO food
research is interested in effects of food structure and therefore wants to
implement the 13C breath test in house, taking into account potential validity
issues.
Study objective
To implement the 13C breath test for measuring gastric emptying rate in healthy
volunteers at NIZO food research. To obtain insight in variation of measures of
gastric emptying for specific model foods.
Study design
Cross-over design, open label pilot study
Intervention
Consumption of two different test meals, labeled with either 13C-acetate or
13C-octanoate, on 3 test days.
Meal 1: full-fat yogurt with sugar
Meal 2: pieces of boiled egg and a glass of chocolate milk with sugar and
sunflower oil
Study burden and risks
There is no direct benefit from participation, although volunteers will be
reimbursed for their time investment. Participants are requested to visit the
study site on three mornings. There are restrictions with respect to eating,
drinking, smoking and physical activity during the test days and on the
evenings before. There are no risks associated with the consumption of the test
foods, which will exist of normal commercially available food ingredients, not
with the use of the 13C tracer compounds or the breath sampling. Blood sampling
by means of finger prick may be experienced as unpleasant.
Kernhemseweg 2
Ede 6718ZB
NL
Kernhemseweg 2
Ede 6718ZB
NL
Listed location countries
Age
Inclusion criteria
• Age 18-35 years
• Use of 3 meals per day
• Voluntary participation (signed informed consent)
• Willing to comply with study procedures
• Accept disclosure of the financial benefit of participation in the study to the authorities concerned
- Accept reporting of abnormal blood glucose values to volunteer or his/her physician
Exclusion criteria
• Smoking
• Current or previous underlying disease of the GI tract, liver, bile bladder, thyroid gland (self-reported)
• Allergy to ingredients in the test products.
• Use of antacids or laxatives (up till 1 month prior to inclusion)
• Pregnancy and lactation
• Vegetarians or vegans
• Drug use
• Personnel of NIZO food research, their partner and their first and second degree relatives
• Participation in any clinical trial up to 30 days before Day 01 of this 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 | NL53172.081.15 |