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Completed

NCT Number: NCT02511366

Repetitive Brake Activation

The appearance of intact macronutrients in the small intestine induces 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. Several studies showed that intraileal infusion of nutrients resulted in a reduction in food intake. However only acute effects were investigated in these studies and thus far it is not known whether repetitive (intermittent) infusion results in adaptation to repeated exposure and, thus, a lowered ileal brake response.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maastricht University Medical Center

Maastricht, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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. Furthermore, we think this study would be too invasive for subjects over the age of 65. 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

  • 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
  • Evidence of casein or hypersensitivity

Treatment and study plan

Ileal infusion of casein

Other

Intraileal infusion of casein

Ileal infusion of tap water

Other

Intraileal infusion of tap water

Other names: placebo

Primary outcomes

  1. Ad libitum food intake

    Time frame: 1 Day

    Ad libitum food intake will be measured in kcal and the end of each test day (4 in total, all within one week)

Secondary outcomes

  1. Satiety

    Time frame: 1 Day

    Visual analogue scale forms for satiety (0-100 mm scale) wil be filled in during each test day (4 in total, all within one week)

  2. Gastrointestinal peptide release (CCK)

    Time frame: 1 Day

    Blood will be drawn during each test day (multiple time points) (4 in total, all within one week)

  3. Gastrointestinal peptide release (GLP-1)

    Time frame: 1 Day

    Blood will be drawn during each test day (multiple time points) (4 in total, all within one week)

  4. Gastrointestinal peptide release (PYY)

    Time frame: 1 Day

    Blood will be drawn during each test day (multiple time points) (4 in total, all within one week)

  5. Gastrointestinal peptide release (insulin)

    Time frame: 1 Day

    Blood will be drawn during each test day (multiple time points) (4 in total, all within one week)

  6. Gastrointestinal peptide release (glucose)

    Time frame: 1 Day

    Blood will be drawn during each test day (multiple time points) (4 in total, all within one week)

  7. gastric emptying rate

    Time frame: 1 Day

    Gastric emptying rate with 13C octanoic acid breath test to determine T1/2

  8. Gallbladder volume

    Time frame: 1 Day

    Gallbladder measurements with ultrasound (volume of GB in mL will be scored)

  9. Small intestinal transit time

    Time frame: 1 Day

    Small intestinal transit time measurements with H2 breath analyser and lactulose

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Registry information

Official study title

The Effect of Repetitive Ileal Brake Activation on Food Intake, Satiety, Gastrointestinal Peptide Release, Gastric Emptying and Gallbladder Volume

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jul 30, 2015
Registry last updated
Nov 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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