Status:
COMPLETED
Oro-gastro-intestinal Digestion of Emulsified Fat
Lead Sponsor:
Maastricht University Medical Center
Collaborating Sponsors:
Top Institute Food and Nutrition
Conditions:
Obesity
Eligibility:
All Genders
18-55 years
Phase:
NA
Brief Summary
Interaction of fat with the mouth, stomach and intestine will trigger physiological responses that will impact on the digestion, gut transit time and absorption of fat. These responses will also influ...
Eligibility Criteria
Inclusion
- Signed informed consent form
- Sex: male or female
- Age: 18-55 years
- Body Mass Index (BMI): 18-29 kg/m2
- Based on medical history and previous examination, no gastrointestinal complaints can be defined.
Exclusion
- 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
- Gastrointestinal or hepatic disorders influencing gastrointestinal absorption or transit
- Use of psychotropic drugs, including: benzodiazepines. Concomitant medication that can increase gastric pH (e.g. antacids, proton pump inhibitors, prostaglandins, anticholinergic agents, H2-receptor antagonists), or alter gastric emptying (e.g. metoclopramide, cisapride, domperidone and erythromycin, anticholinergics, tricyclic antidepressants, 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), except oral contraceptives
- Pregnancy, lactation, wish to become pregnant during study, or having a positive pregnancy test at inclusion
- Reported unexplained weight loss/gain of more than 2 kg in the month before the study enrollment
- Score \> 9 on Factor 1 (dietary restrained) of the Dutch translation of the Three Factor eating Questionnaire (TFEQ) \[17\]
- Blood donations less than three months previous to study enrollment, and for three months following participation
- One or more of the following dietary habits: medically prescribed diets, weight reduction diets, or vegetarian/macrobiotic/biologically dynamic food habits. Administration of investigational drugs in the 180 days prior to the study
- Major abdominal surgery interfering with gastrointestinal function (uncomplicated appendectomy, cholecystectomy and hysterectomy allowed, and other surgery upon judgement of the principle investigator)
- Premenstrual syndrome, dieting (medically prescribed, vegetarian, diabetic, biological dynamic)
- Excessive alcohol consumption (\>20 alcoholic consumptions per week)
- Smoking
- Self-admitted HIV-positive state
Key Trial Info
Start Date :
December 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT01478750
Start Date
December 1 2009
End Date
June 1 2011
Last Update
October 25 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Maastricht University Medical Centre
Maastricht, Netherlands, NL-6200MD