The Effect of Different Macronutrients on Ileal Brake Activation
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ClinicalTrials.gov Identifier: NCT01509469 |
Recruitment Status
:
Completed
First Posted
: January 13, 2012
Last Update Posted
: January 29, 2014
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Tracking Information | ||||
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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 |
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 |
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 |
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Original Secondary Outcome Measures ICMJE |
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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. |
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Study Type ICMJE | Interventional | |||
Study Phase | Not Applicable | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double (Participant, Investigator) Primary Purpose: Prevention |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms |
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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. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender |
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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 |
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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 |