Repetitive Brake Activation

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Eating; Ileal Brake
• Intervention / Treatment: Other: Ileal infusion of casein; Other: Ileal infusion of tap water

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Maastricht, Netherlands
    • Maastricht University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: ileal infusion of casein; Ileal infusion of casein	Other: Ileal infusion of casein; Intraileal infusion of casein
PLACEBO_COMPARATOR: ileal infusion of tap water	Other: Ileal infusion of tap water; Intraileal infusion of tap water; Other Names: placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ad libitum food intake	Ad libitum food intake will be measured in kcal and the end of each test day (4 in total, all within one week)	1 Day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satiety	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)	1 Day
Gastrointestinal peptide release (CCK)	Blood will be drawn during each test day (multiple time points) (4 in total, all within one week)	1 Day
Gastrointestinal peptide release (GLP-1)	Blood will be drawn during each test day (multiple time points) (4 in total, all within one week)	1 Day
Gastrointestinal peptide release (PYY)	Blood will be drawn during each test day (multiple time points) (4 in total, all within one week)	1 Day
Gastrointestinal peptide release (insulin)	Blood will be drawn during each test day (multiple time points) (4 in total, all within one week)	1 Day
Gastrointestinal peptide release (glucose)	Blood will be drawn during each test day (multiple time points) (4 in total, all within one week)	1 Day
gastric emptying rate	Gastric emptying rate with 13C octanoic acid breath test to determine T1/2	1 Day
Gallbladder volume	Gallbladder measurements with ultrasound (volume of GB in mL will be scored)	1 Day
Small intestinal transit time	Small intestinal transit time measurements with H2 breath analyser and lactulose	1 Day

Collaborators and Investigators

• Sponsor: Maastricht University Medical Center
• Investigators: Principal Investigator: A. Masclee, Prof dr., Maastricht University Medical Center

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (ACTUAL): November 1, 2015
• Study Completion (ACTUAL): November 1, 2015

Study Registration Dates

• First Submitted: April 9, 2015
• First Submitted That Met QC Criteria: July 27, 2015
• First Posted (ESTIMATE): July 30, 2015

Study Record Updates

• Last Update Posted (ESTIMATE): November 3, 2015
• Last Update Submitted That Met QC Criteria: November 2, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: ileal brake
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Chelating Agents; Sequestering Agents; Caseins
• Other Study ID Numbers: NL50301.068.14