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Effect of droplet size of a fat emulsion, when given directly into the small intestinell intestinal on satiety and food intake in healthy volunteers.


- candidate number4317
- NTR NumberNTR1515
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR31-okt-2008
- Secondary IDs04C9 P04.224
- Public TitleEffect of droplet size of a fat emulsion, when given directly into the small intestinell intestinal on satiety and food intake in healthy volunteers.
- Scientific TitleEffect of droplet size of a fat emulsion delivered in the small intestinal on satiety and food intake in healthy volunteers.
- ACRONYMN/A
- hypothesisLong-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.
- Healt Condition(s) or Problem(s) studiedOverweight, Obesity
- Inclusion criteria1. Signed informed consent form
2. Sex: male or female
3. Age: 18-55 years
4. Body Mass Index (BMI): 18-32 kg/m2
- Exclusion criteria1. 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
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlNot applicable
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 26-apr-2005
- planned closingdate15-jul-2005
- Target number of participants15
- Interventions6 g of fine (droplet size 1 micron) or coarse (droplet size 15 micron) oil emulsion will be administered to the duodenum or the ileum.
- Primary outcomeTo 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 outcomeTo 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.
- Timepointst=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
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESMD P.W.J. Maljaars
- CONTACT for SCIENTIFIC QUERIESMD P.W.J. Maljaars
- Sponsor/Initiator University Hospital Maastricht (AZM), Department of Internal Medicine
- Funding
(Source(s) of Monetary or Material Support)
Unilever Research Vlaardingen, Unilever Health Institute
- PublicationsN/A
- Brief summary
- Main changes (audit trail)
- RECORD31-okt-2008 - 28-nov-2008


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