No registrations found.
ID
Source
Brief title
Health condition
Obesity.
Sponsors and support
PO box 9600
2300 RC Leiden
fax nr.:0715248115
tel. nr.:0715263507
Energy, Weight Control and Performance skill base
Unilever Research Vlaardingen
PO Box 114
3130 AC Vlaardingen
The Netherlands
Intervention
Outcome measures
Primary outcome
To 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 outcome
To 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).
Background summary
In 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.
Study objective
Long-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.
Study design
N/A
Intervention
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.
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.
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 |
|---|---|
| NTR-new | NL441 |
| NTR-old | NTR481 |
| Other | : N/A |
| ISRCTN | ISRCTN51742545 |