Primary objectiveTo measure the conversion rate of mono- and disaccharides into oligosaccharides and mannitol in the digestive tract by the action of food grade micro-organisms Secondary objectivesTo measure pH of gastric and duodenal fluids at…
ID
Source
Brief title
Condition
- Metabolism disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Sugar conversion. This by measuring:
• Fructo- and Gluco-oligosaccharides
• Mannitol
• Sucrose
• Fructose
• Glucose
Secondary outcome
• Phenol red (marker for gastric emptying)
• pH
• Number of viable bacteria
Background summary
This pilot study aims to reduce the caloric contribution of sugars in a meal by
converting mono- and di- saccharides in to oligosaccharides and mannitol in the
digestive tract, with the help of enzymes or micro-organisms in a drink. For
this, three strains of Lactobacillus reuteri (ATCC55730, DSM17938 and 121),
Lactobacillus gasseri BNR17 and two strains of Lduconostoc mesenteroides
(ATCC8293 and NCIMB701875) will be used.
Study objective
Primary objective
To measure the conversion rate of mono- and disaccharides into oligosaccharides
and mannitol in the digestive tract by the action of food grade micro-organisms
Secondary objectives
To measure pH of gastric and duodenal fluids at different time points
To measure gastric emptying rate of the test drink
To measure the number of viable bacteria at different time points in the
stomach and the duodenum, after ingestion of a test drink.
Study design
We will implement a randomised, double-blinded cross-design
Intervention
placement of a naso-duodenal catheter and hereafter consumption of two oral
probiotic preparations at two different occasions
Study burden and risks
Placement of catheter involves a small risk of perforation. Positioning of the
catheter involves radiation risk equal to a one hour flight in an aeroplane at
4 km altitude
P.O. Box 616
6200 MD
Nederland
P.O. Box 616
6200 MD
Nederland
Listed location countries
Age
Inclusion criteria
sex: male
age: 18-40 years
body mass index 18-30kg/m2
Exclusion criteria
• History of severe cardiovascular, respiratory, urogenital, gastrointestinal/ hepatic, hematological/immunologic, HEENT (head, ears, eyes, nose, throat), dermatological/connective tissue, musculoskeletal, metabolic/nutritional, endocrine, neurological/psychiatric diseases, allergy, major surgery which might limit participation in or completion of the study protocol
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 | NL29748.068.09 |