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The effect of different macronutrients on the ileal brake

The effect of different macronutrients on the ileal brake - Macronutrients and the ileal brake

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON37970
Enrollment
17
Registered
2011-06-30
Start date
2012-04-13
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesitas Obesity and overweight

Interventions

Healthy volunteers will compleet 6 test days in total. Every test day another substance will be infused into the ileum via the nasoileal catheter: casein (high and low dose), sucrose (high and low do

Sponsors

Medisch Universitair Ziekenhuis Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Main study parameter/endpoint - Difference in satiation (as measured by VAS) per time points and difference in food intake as measured during an ad libitum meal

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)