obesity, overweight, weight management
Conditions
Interventions
Sponsors
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
| Measure | Time 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
| Measure | Time frame |
|---|---|
| Secondary parameters are plasma concentrations of gut peptides and difference in gastric emptying T1/2 and small bowel transit time. | — |
Contacts
University Hospital Maastricht (azM) Department of Internal Medicine Division of Gastroenterology & Hepatology PO Box 5800