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The effect of intraileal infusion of fat emulsions, differing in degree of saturation, on satiety and food intake after a liquid meal replacement.


- candidate number1683
- NTR NumberNTR481
- ISRCTNISRCTN51742545
- Date ISRCTN created27-jan-2006
- date ISRCTN requested18-nov-2005
- Date Registered NTR15-sep-2005
- Secondary IDsN/A 
- Public TitleThe effect of intraileal infusion of fat emulsions, differing in degree of saturation, on satiety and food intake after a liquid meal replacement.
- Scientific TitleThe effect of intraileal infusion of fat emulsions, differing in degree of saturation, on satiety and food intake after a liquid meal replacement.
- ACRONYMN/A
- hypothesisLong-chain triglyceride (LCT) emulsions with di-unsaturated fatty acids will lead to enhanced postprandial satiety and reduced energy intake in a subsequent meal, as compared to LCT emulsions with mono-unsaturated or saturated fatty acids.
- 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.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 26-sep-2005
- planned closingdate24-dec-2005
- Target number of participants15
- InterventionsSaline (control) or a 5 g emulsion consisting either of mainly unsaturated fats (18:0), mono-unsaturated fat (18:1) or di-unsaturated fat (18:2) will be administered to the ileum on 4 consecutive days, using a 270 cm catheter.
- Primary outcomeTo assess whether emulsions differing in degree of saturation, have different effects when administered in the ileum, on satiety as measured by visual analogue scales, and food intake during ad libitum lunch.
- Secondary outcomeTo assess the effect of emulsions differing in degree of saturation, when infused in the ileum on gastric emptying, intestinal transit time and on secretion of peptides known to affect satiety.
Peptides we will measure are Ghrelin and CCK as proximal gut hormones and Apo A-IV and PYY as distal gut hormones (ileal brake).
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESMD P.W.J. Maljaars
- CONTACT for SCIENTIFIC QUERIESMD. PhD. A.A.M. Masclee
- Sponsor/Initiator Leiden University Medical Center (LUMC), Department of Gastroenterology and Hepatology
- Funding
(Source(s) of Monetary or Material Support)
Unilever Research Vlaardingen, Unilever Health Institute
- PublicationsN/A
- Brief summaryIn a double blind placebo controlled crossover design, saline (control) or a 5 g emulsion consisting either of mainly unsaturated fats (18:0), mono-unsaturated fat (18:1) or di-unsaturated fat (18:2) will be administered to the ileum on 4 consecutive days, using a 270 cm catheter.
- Main changes (audit trail)
- RECORD15-sep-2005 - 1-okt-2008


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