The effect of different macronutrients on the ileal brake

Completed

• Conditions: Obesitas; Obesity and overweight; 10003018

• Registration Number: NL-OMON37970
• Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2013-04-07
• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 17

Inclusion Criteria

1) Based on medical history and previous examination, no gastrointestinal complaints can be defined.
2) 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.
3) BMI between 18 and 29 kg/m2
4) Less then 2 *yes* responses in the SCOFF questionnaire (see appendix F1)
5) Weight stable over at least the last 6 months

Exclusion Criteria

1) 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.
2) Use of medication, including vitamin supplementation, except oral contraceptives, within 14 days prior to testing
3) 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
4) Major abdominal surgery interfering with gastrointestinal function (uncomplicated appendectomy, cholecystectomy and hysterectomy allowed, and other surgery upon judgement of the principle investigator)
5) Dieting (medically prescribed, vegetarian, diabetic, macrobiological, biological dynamic)
6) Pregnancy, lactation
7) Excessive alcohol consumption (>20 alcoholic consumptions per week)
8) Smoking
9) Blood donation within 3 months before the study period
10) Self-admitted HIV-positive state
11) Eating disorders detected using the *SCOFF questionnaire* (in Dutch translation)
12) Lactose or Cow milk intolerance

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main study parameter/endpoint<br /><br>- Difference in satiation (as measured by VAS) per time points and difference<br /><br>in food intake as measured during an ad libitum meal</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study parameters/endpoints<br /><br>- Measurements in plasma and/or platelet poor plasma Plasma levels of the gut<br /><br>hormones Cholecystokinin (CCK), Glucagon Like Peptide-1 (GLP-1) and peptide YY<br /><br>(PYY)<br /><br><br /><br>Other study parameters:<br /><br>- Gastric emptying by using the C13 stable isotope breath test<br /><br>- Small bowel transit time by using lactulose hydrogen breath test<br /><br>- Gallbladder emptying by gallbladder ultrasound</p><br>