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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.

Effect of droplet size of a fat emulsion delivered in the small intestinal on satiety and food intake in healthy volunteers.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON26271
Enrollment
15
Registered
2008-10-31
Start date
2005-04-26
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity Overgewicht, obesitas

Interventions

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.

Sponsors

Jeroen Maljaars 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
Lead Sponsor

Eligibility

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Contacts

Public ContactP.W.J. Maljaars

University Hospital Maastricht (azM) Department of Internal Medicine Divison of Gastroenterology & Hepatology PO Box 5800

PWJ.Maljaars@INTMED.unimaas.nl+31 (0)43 3882983

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)