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Influence of distribution of small intestinal delivery of fat on satiety and energy intake in healthy volunteers.

Influence of distribution of small intestinal delivery of fat on satiety and energy intake in healthy volunteers.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON27589
Enrollment
15
Registered
2008-12-11
Start date
2007-09-01
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, overweight, weight management

Interventions

After intubation with a naso-ileal catheter, volunteers will three times receive an intra-intestinal infusion with a fat emulsion, and once a saline control.

Sponsors

Division of Gastroenterology, Department of Internal Medicine, University Hospital Maastricht (AZM)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Sex: male or female; 2. Age: 18-55 years; 3. Body mass index(BMI): 18-29 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. 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; 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; 11. Reported working on late/night shifts.

Design outcomes

Primary

MeasureTime frame
The main study parameters are differences in satiety scores (as measured by visual analogue scale (VAS)) per time point and as AUC and differences in food intake during an ad libitum meal.

Secondary

MeasureTime frame
Secondary parameters are plasma concentrations of gut peptides and difference in gastric emptying T1/2 and small bowel transit time.

Contacts

Public ContactJ Maljaars

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

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

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)