Location Specific Differences in Intestinal Brake Activation
Primary Purpose
Ileal Brake, Satiety, Overweight
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
placebo
Casein (in duodenum)
Casein (in jejunum)
Casein (in ileum)
Sponsored by
About this trial
This is an interventional basic science trial for Ileal Brake
Eligibility Criteria
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
Sites / Locations
- Maastricht University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Experimental
Experimental
Experimental
Arm Label
Placebo
Duodenum
Jejunum
Ileum
Arm Description
Tap water infusion in all three locations (duodenum, jejunum and ileum)
Infusion of casein in duodenum
Infusion of casein in jejunum
Infusion of casein in ileum
Outcomes
Primary Outcome Measures
To measure ad libitum food intake at the end of the test day
Food intake measurement in kcal
Secondary Outcome Measures
VAS scores for hunger and satiety
Visual analogue scale for hunger and satiety in mm (0-100 mm scale)
GI peptides
Measurement of GI peptide release during protein infusion (CCK, GLP-1, PYY, insulin and glucose)
Full Information
NCT ID
NCT02500069
First Posted
March 18, 2014
Last Updated
July 14, 2015
Sponsor
Maastricht University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02500069
Brief Title
Location Specific Differences in Intestinal Brake Activation
Official Title
The Effect of Intestinal Brake Activation at Different Locations in the Gut on Food Intake and Hormone Release
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
March 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ileal Brake, Satiety, Overweight, Obesity, Overeating
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Tap water infusion in all three locations (duodenum, jejunum and ileum)
Arm Title
Duodenum
Arm Type
Experimental
Arm Description
Infusion of casein in duodenum
Arm Title
Jejunum
Arm Type
Experimental
Arm Description
Infusion of casein in jejunum
Arm Title
Ileum
Arm Type
Experimental
Arm Description
Infusion of casein in ileum
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
infusion of tap water in all regions (duodenum, jejunum and ileum)
Intervention Type
Other
Intervention Name(s)
Casein (in duodenum)
Intervention Description
infusion of protein in duodenum
Intervention Type
Other
Intervention Name(s)
Casein (in jejunum)
Intervention Description
infusion of protein in jejunum
Intervention Type
Other
Intervention Name(s)
Casein (in ileum)
Intervention Description
infusion of protein in ileum
Primary Outcome Measure Information:
Title
To measure ad libitum food intake at the end of the test day
Description
Food intake measurement in kcal
Time Frame
1 test day
Secondary Outcome Measure Information:
Title
VAS scores for hunger and satiety
Description
Visual analogue scale for hunger and satiety in mm (0-100 mm scale)
Time Frame
1 test day
Title
GI peptides
Description
Measurement of GI peptide release during protein infusion (CCK, GLP-1, PYY, insulin and glucose)
Time Frame
1 test day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
A Masclee, Prof. dr.
Organizational Affiliation
Maastricht University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maastricht University Medical Center
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
6003
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
27811949
Citation
van Avesaat M, Ripken D, Hendriks HF, Masclee AA, Troost FJ. Small intestinal protein infusion in humans: evidence for a location-specific gradient in intestinal feedback on food intake and GI peptide release. Int J Obes (Lond). 2017 Feb;41(2):217-224. doi: 10.1038/ijo.2016.196. Epub 2016 Nov 4.
Results Reference
derived
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Location Specific Differences in Intestinal Brake Activation
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