Ileal brake activation and Weight loss
Conditions
Interventions
Ingestion of micro encapsulated casein and sucrose (ileal delivery)
Sponsors
Medisch Universitair Ziekenhuis Maastricht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: * Based on medical history and previous examination, no gastrointestinal complaints can be defined. * Age between 18 and 65 years. A higher age comes with a higher chance of comorbidities. These could influence our study outcomes and therefore this age range was chosen. This study will include healthy adult subjects (male and female). Women must be taking contraceptives (only needed in women with childbearing potential) * BMI between 25 -30 kg/m2 * Normal Dutch eating habits eating three meals a day including breakfast as assessed by an validated questionnaire * Voluntary participation * Able to participate in the study, willing to give informed consent and to comply with the study procedures and restrictions
Exclusion criteria
Exclusion criteria: * History of severe cardiovascular, respiratory, urogenital, gastrointestinal/ hepatic, hematological/immunologic, 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 and documented by the principal investigator. * Use of any medication, except oral contraceptives, which may interfere with this study (major interference with the execution of the experiment or potential influence on the study outcomes). This has to be decided and documented by the principle investigator. * 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 90 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, diabetic and vegetarian) * Pregnancy, lactation * Excessive alcohol consumption (>20 alcoholic consumptions per week) * Intention to stop smoking * Self-admitted HIV-positive state * * Above average score (>3.39 for female and >2.89 for male) on the restrained eating scale of the Dutch Eating Behaviour Questionnaire * Reported unexplained weight loss or gain of >4 kg in the month prior to screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| First part of study (Phase 1) Aim: To evaluate the efficacy of ileal brake activation, by ingestion of an encapsulated nutrient mixture delivered to the stomach (placebo) or distal small intestine (active) analysed by the amount of food consumed during a subsequent ad libitum meal. Hypothesis: We hypothesize that delivery of encapsulated nutrient mixture to the distal small intestine (active) results in a reduction in food intake compared to encapsulated nutrient mixture delivery to the stomach (placebo). Primary objective: To investigate whether delivery of an encapsulated nutrient mixture to the distal small intestine (active) decreases the amount of food consumed during a subsequent ad libitum meal compared to delivery of an encapsulated nutrient mixture to the stomach (placebo). Main study (Phase 2) Aim: To investigate the effect of six weeks ileal brake activation by nutrient delivery to the distal small intestine (active) on body weight. This will be studied by daily ingestion of an encapsulated nutrient mixture which will be delivered to the distal small intestine (active) or stomach (placebo) before lunch and dinner for a period of 42 ± 2 days (6 weeks). Hypothesis: We hypothesize that 6 weeks ileal brake activation by nutrient delivery to the distal small intestine (active) at lunch and dinner results in body weight reduction. Primary objective: The difference in body weight before and after 6 weeks ileal brake activation by nutrient delivery to the distal small intestine (active; group 1) compared to nutrient mixture delivery to the stomach (placebo; group 2). | — |
Secondary
| Measure | Time frame |
|---|---|
| First part of study (Phase 1) Secondary objective: To investigate whether intake of encapsulated nutrient mixture delivered to the distal small intestine (active) increases satiation compared to delivery of the encapsulated nutrient mixture to the stomach (placebo), as analysed by VAS-scores. Tertiary objective: To analyse whether the appearance of glucose and insulin is delayed in plasma after encapsulated nutrient delivery to the distal small intestine (active) compared to encapsulated nutrient delivery to the stomach (placebo). Main study (Phase 2) Secondary objective: To investigate whether intake of encapsulated nutrient mixture delivered in the distal small intestine (active) decreases the amount of food consumed during a subsequent ad libitum meal compared to encapsulated nutrient mixture delivered in the stomach (placebo) in time, analysed pre-, middle and post intervention. Tertiary objective: To investigate whether intake of encapsulated nutrient mixture (active) increases satiation analysed by VAS-scores compared to placebo pre, middle and post intervention. Other objective(s): To evaluate effects of 6 weeks encapsulated nutrient delivery to the distal small intestine (active) on glucose and insulin plasma concentrations compared to nutrient delivery to the stomach (placebo). This will be analysed by monitor blood glucose and insulin responses in time pre- and post intervention. | — |
Countries
Netherlands
Outcome results
None listed