The Effect of Different Macronutrients on Ileal Brake Activation

Tracking Information
First Submitted Date ICMJE	August 9, 2011
First Posted Date ICMJE	January 13, 2012
Last Update Posted Date	January 29, 2014
Study Start Date ICMJE	March 2012
Actual Primary Completion Date	June 2013 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: January 28, 2014)	Difference in satiation (as measured by VAS) and food intake as measured during an ad libitum meal [ Time Frame: 1 day ]
Original Primary Outcome Measures ICMJE; (submitted: January 10, 2012)	Difference in satiation (as measured by VAS) per time points [ Time Frame: 1 day ]
Change History	Complete list of historical versions of study NCT01509469 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: January 28, 2014)	Measurements in plasma and/or platelet poor plasma Plasma levels of the gut hormone Cholecystokinin (CCK) [ Time Frame: 1 day ]; Gastric emptying by using the C13 stable isotope breath test [ Time Frame: 1 day ]; Small bowel transit time by using lactulose hydrogen breath test [ Time Frame: 1 day ]; Gallbladder volumes by gallbladder ultrasound [ Time Frame: 1 day ]; Measurements in plasma and/or platelet poor plasma Plasma levels of the gut hormone Glucagon Like Peptide-1 (GLP-1) [ Time Frame: 1 day ]; Measurements in plasma and/or platelet poor plasma Plasma levels of the gut hormone peptide YY (PYY) [ Time Frame: 1 day ]
Original Secondary Outcome Measures ICMJE; (submitted: January 10, 2012)	Measurements in plasma and/or platelet poor plasma Plasma levels of the gut hormone Cholecystokinin (CCK) [ Time Frame: 1 day ]; Gastric emptying by using the C13 stable isotope breath test [ Time Frame: 1 day ]; Small bowel transit time by using lactulose hydrogen breath test [ Time Frame: 1 day ]; Gallbladder volumes by gallbladder ultrasound [ Time Frame: 1 day ]; Measurements in plasma and/or platelet poor plasma Plasma levels of the gut hormone Glucagon Like Peptide-1 (GLP-1) [ Time Frame: 1 day ]; Measurements in plasma and/or platelet poor plasma Plasma levels of the gut hormone peptide YY (PYY) [ Time Frame: 1 day ]; Difference in food intake as measured during an ad libitum meal [ Time Frame: 1 day ]
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	The Effect of Different Macronutrients on Ileal Brake Activation
Official Title ICMJE	The Effect of Different Macronutrients on Ileal Brake Activation
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 intestine and to the central nervous system. All these processes inhibit, in concert, food processing in the gastrointestinal tract, satiation and appetite sensations and, consequently, food intake. These processes are involved in the so-called intestinal brake. The location at which the feedback process is initiated determines the severity of the brake effect; the entry of nutrients into the duodenum and jejunum activates the so-called duodenal and jejunal "brakes": negative feedback mechanisms that influence the function of more proximal parts of the gastrointestinal tract. Activation of both of these feedback mechanisms results in reduction of food intake and inhibition of hunger, probably partly by inhibition of gastric emptying rate (thus contributing to enhanced and prolonged gastric distension) and small intestinal transit time. More distal in the small intestine, the ileal brake is a feedback mechanism that results in inhibition of proximal gastrointestinal motility and secretion and increase feelings of satiation and reduction of ad libitum food intake.These results all point to a potentially powerful role of the ileal brake in the regulation of digestion, with direct or indirect impact upon eating behaviour and satiation. The current scientific data strongly suggest that activation of the ileal brake provides the most powerful feedback mechanism to gastrointestinal transit and, especially, satiety signals and food intake. Most studies have used fat as macronutrient. The effects of several amounts, types and preparations of fat on the ileal brake have previously been investigated and reported. Until present, the effects of the other macronutrients to induce the ileal brake remain largely unknown. There is evidence that carbohydrates induce the ileal brake. Proteins may also exert effects, although data are scarce and not convincing. However, it becomes more and more accepted that proteins may induce stronger effects on satiation and food intake than fat or carbohydrates. In this study we're going to investigate the effect of intraileal infusion of casein and sucrose on ileal brake activation.
Study Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Prevention
Condition ICMJE	Obesity; Overweight
Intervention ICMJE	Dietary Supplement: Casein Ileal infusion of low dose casein (5 gram); Dietary Supplement: Casein Ileal infusion of high dose casein (15 gram); Dietary Supplement: Sucrose Ileal infusion of low dose sucrose (4.3 gram); Dietary Supplement: Sucrose Ileal infusion of high dose sucrose (12.9 gram); Other: Saline Ileal infusion with saline (180mL in total); Dietary Supplement: Safflower oil Ileal infusion with safflower oil (6gr safflower oil in water)
Study Arms	Experimental: Low dose casein Ileal infusion of low dose casein Intervention: Dietary Supplement: Casein; Experimental: High dose casein Ileal infusion of high dose casein Intervention: Dietary Supplement: Casein; Experimental: Low dose sucrose Ileal infusion of low dose sucrose Intervention: Dietary Supplement: Sucrose; Experimental: High dose sucrose Ileal infusion of high dose sucrose Intervention: Dietary Supplement: Sucrose; Placebo Comparator: Placebo Ileal infusion saline Intervention: Other: Saline; Active Comparator: Safflower oil Ileal infusion safflower oil Intervention: Dietary Supplement: Safflower oil
Publications *	Ripken D, van Avesaat M, Troost FJ, Masclee AA, Witkamp RF, Hendriks HF. Intraileal casein infusion increases plasma concentrations of amino acids in humans: A randomized cross over trial. Clin Nutr. 2017 Feb;36(1):143-149. doi: 10.1016/j.clnu.2016.01.012. Epub 2016 Jan 29.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: January 10, 2012)	15
Original Estimated Enrollment ICMJE	Same as current
Actual Study Completion Date	June 2013
Actual Primary Completion Date	June 2013 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: 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 Criteria: 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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 55 Years (Adult)
Accepts Healthy Volunteers	Yes
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Netherlands
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01509469
Other Study ID Numbers ICMJE	NL36916.068.11
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Mark van Avesaat, Maastricht University Medical Center
Study Sponsor ICMJE	Maastricht University Medical Center
Collaborators ICMJE	Top Institute Food and Nutrition
Investigators ICMJE	Principal Investigator: A. Masclee, Prof. Maastricht University Medical Centre +
PRS Account	Maastricht University Medical Center
Verification Date	January 2014
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP