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Location Specific Differences in Intestinal Brake Activation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02500069
Recruitment Status : Completed
First Posted : July 16, 2015
Last Update Posted : July 16, 2015
Information provided by (Responsible Party):
Maastricht University Medical Center

Brief Summary:
The appearance of intact macronutrients in the small intestine can result in the activation of an intestinal brake; a negative feedback mechanism from different parts of the intestine to the stomach, the small intestine and to the central nervous system. These processes inhibit food processing, appetite sensations and food intake, and furthermore they increase feelings of satiety and satiation. The researchers will investigate the effects of intraduodenal, intrajejunal and intralileal infusion of casein (protein) on ad libitum food intake, satiation and in vivo release of the gut satiety peptides CCK, PYY and GLP-1 and glucose and insulin.

Condition or disease Intervention/treatment Phase
Ileal Brake Satiety Overweight Obesity Overeating Other: placebo Other: Casein (in duodenum) Other: Casein (in jejunum) Other: Casein (in ileum) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: The Effect of Intestinal Brake Activation at Different Locations in the Gut on Food Intake and Hormone Release
Study Start Date : May 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Casein

Arm Intervention/treatment
Placebo Comparator: Placebo
Tap water infusion in all three locations (duodenum, jejunum and ileum)
Other: placebo
infusion of tap water in all regions (duodenum, jejunum and ileum)

Experimental: Duodenum
Infusion of casein in duodenum
Other: Casein (in duodenum)
infusion of protein in duodenum

Experimental: Jejunum
Infusion of casein in jejunum
Other: Casein (in jejunum)
infusion of protein in jejunum

Experimental: Ileum
Infusion of casein in ileum
Other: Casein (in ileum)
infusion of protein in ileum

Primary Outcome Measures :
  1. To measure ad libitum food intake at the end of the test day [ Time Frame: 1 test day ]
    Food intake measurement in kcal

Secondary Outcome Measures :
  1. VAS scores for hunger and satiety [ Time Frame: 1 test day ]
    Visual analogue scale for hunger and satiety in mm (0-100 mm scale)

  2. GI peptides [ Time Frame: 1 test day ]
    Measurement of GI peptide release during protein infusion (CCK, GLP-1, PYY, insulin and glucose)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion criteria

In order to be eligible to participate in this study, a subject must meet all of the following criteria:

  • Based on medical history and previous examination, no gastrointestinal complaints can be defined.
  • Age between 18 and 65 years. This study will include healthy adult subjects (male and female). Women must be taking contraceptives.
  • BMI between 18 and 25 kg/m2)
  • Weight stable over at least the last 6 months (≤5% weight change)

Exclusion criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:

  • 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
  • Weight <60kg
  • Evidence of casein or sucrose hypersensitivity
  • Participation in any other study in which radiation was used, within 12 months before the study period

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02500069

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Maastricht University Medical Center
Maastricht, Limburg, Netherlands, 6003
Sponsors and Collaborators
Maastricht University Medical Center
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Principal Investigator: A Masclee, Prof. dr. Maastricht University Medical Center
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Maastricht University Medical Center Identifier: NCT02500069    
Other Study ID Numbers: METC-14-3-006
First Posted: July 16, 2015    Key Record Dates
Last Update Posted: July 16, 2015
Last Verified: July 2015
Additional relevant MeSH terms:
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Body Weight
Signs and Symptoms
Signs and Symptoms, Digestive
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action