No registrations found.
ID
Source
Brief title
Health condition
Obesity
Overgewicht, obesitas
Sponsors and support
Division of Gastroenterology-Hepatology
University Hospital Maastricht.
PO Box 5800
2602 AZ Maastricht
The Netherlands
Email:PWJ.Maljaars@intmed.unimaas.nl
Tel: +31(0)433882983
Fax: +31(0)433875006
Intervention
Outcome measures
Primary outcome
To assess whether the fat droplet size in an emulsion affects satiety (as measured by visual analogue scales) and food intake (during ad libitum lunch) when infused into the duodenum and when infused into the ileum.
Secondary outcome
To assess whether the fat droplet size in an emulsion affects gastric emptying, intestinal transit time and secretion of peptides known to affect satiety (CCK, PYY) when infused into the duodenum and when infused into the ileum.
Study objective
Long-chain triglyceride (LCT) emulsions with very small droplet sizes (fine emulsion) will lead to enhanced postprandial satiety and reduced energy intake in a subsequent meal, as compared to LCT emulsions with relatively large droplet sizes (coarse emulsion). Infusion in the ileum will enlarge this effect as compared to the duodenum.
Study design
t=0
t=30
t=45
t=60
t=75
t=90
t=105
t=120
t=135
t=150
t=165
t=180
t=195
t=210
t=240
Intervention
6 g of fine (droplet size 1 micron) or coarse (droplet size 15 micron) oil emulsion will be administered to the duodenum or the ileum.
Department of Internal Medicine
Divison of Gastroenterology & Hepatology<br>
PO Box 5800
P.W.J. Maljaars
Maastricht 6202 AZ
The Netherlands
+31 (0)43 3882983
PWJ.Maljaars@INTMED.unimaas.nl
Department of Internal Medicine
Divison of Gastroenterology & Hepatology<br>
PO Box 5800
P.W.J. Maljaars
Maastricht 6202 AZ
The Netherlands
+31 (0)43 3882983
PWJ.Maljaars@INTMED.unimaas.nl
Inclusion criteria
1. Signed informed consent form
2. Sex: male or female
3. Age: 18-55 years
4. Body Mass Index (BMI): 18-32 kg/m2
Exclusion criteria
1. Evidence 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 and/or laboratory assessments which might limit participation in or completion of the study protocol
2. Gastrointestinal or hepatic disorders influencing gastrointestinal absorption or transit
3. The use of psychotropic drugs, including: benzodiazepines or alcohol in excess of 21 units/week for males and 14 units/week for females
4. Concomitant medication that can increase gastric pH (e.g. antacids, protonpump-inhibitors, prostaglandins, anticholinergic agents, H2-receptor antagonists), or alter gastric emptying (e.g. metoclopramide, cisapride, domperidone and erythromycin, anticholinergics, tricyclic antidepresants, narcotic analgetics, adrenergic agents, calcium channel blockers), or alter intestinal transit (e.g. loperamide, chemical/osmotic/bulk laxatives) ,or influence satiety/energy intake (e.g. sibutramine, glucocorticoids, anabolic steroids)
5. Intolerance of Slim Fast product or of ingredients of the ad libitum meal
6. Pregnancy, lactation, wish to become pregnant during study, or having a positive pregnancy test at inclusion
7. Reported unexplained weight loss/gain of more than 2 kg in the month before the study enrollment
8. Eating disorders detected using the “SCOFF” questionnaire (in Dutch translation), and high or very high-restrained eaters as measured by the Dutch Eating Behavior Questionnaire (25;26) – see Appendix 1 and 2.
9. Blood donations less than three months previous to study enrollment
10. One or more of the following dietary habits: medically prescribed diets, weight
reduction diets, or vegetarian/macrobiotic/biologically dynamic food habits
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL1454 |
| NTR-old | NTR1515 |
| Other | P04.224 : 04C9 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |