Status:
COMPLETED
The Effect of Different Macronutrients on Ileal Brake Activation
Lead Sponsor:
Maastricht University Medical Center
Collaborating Sponsors:
Top Institute Food and Nutrition
Conditions:
Obesity
Overweight
Eligibility:
All Genders
18-55 years
Phase:
NA
Brief Summary
The purpose of this study is to determine whether ileal infusion of casein and sucrose can activate the ileal brake.
Detailed Description
The appearance of a food matrix into the duodenum, both during a meal and during the postprandial phase results in a feed-back from different parts of the intestine to the stomach, to the small intest...
Eligibility Criteria
Inclusion
- Based on medical history and previous examination, no gastrointestinal complaints can be defined.
- Age between 18 and 55 years. This study will include healthy adult subjects (Male and Female), Women must be taking oral contraceptives. Subjects over 55 years have an increased risk for comorbidities, therefore, subjects over 55 years will not be included.
- BMI between 18 and 29 kg/m2
- Less then 2 'yes' responses in the SCOFF questionnaire (see appendix F1)
- Weight stable over at least the last 6 months
Exclusion
- History 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. The severity of the disease (major interference with the execution of the experiment or potential influence on the study outcomes) will be decided by the principal investigator.
- Use of medication, including vitamin supplementation, except oral contraceptives, within 14 days prior to testing
- Administration of investigational drugs or participation in any scientific intervention study which may interfere with this study (to be decided by the principle investigator), 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)
- Dieting (medically prescribed, vegetarian, diabetic, macrobiological, biological dynamic)
- Pregnancy, lactation
- Excessive alcohol consumption (\>20 alcoholic consumptions per week)
- Smoking
- Blood donation within 3 months before the study period
- Self-admitted HIV-positive state
- Eating disorders detected using the 'SCOFF questionnaire' (in Dutch translation)
- Lactose or cow milk intolerance
Key Trial Info
Start Date :
March 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT01509469
Start Date
March 1 2012
End Date
June 1 2013
Last Update
January 29 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Maastricht University Medical Center
Maastricht, Limburg, Netherlands