Location Specific Differences in Intestinal Brake Activation

Sponsor

Maastricht University Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT02500069

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.6

Patients Per Site Per Month

Study Details

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.

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)	N/A

Study Design

Study Type:

Interventional

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 1, 2014

Actual Primary Completion Date :

Dec 1, 2014

Actual Study Completion Date :

Mar 1, 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

To measure ad libitum food intake at the end of the test day [1 test day]
Food intake measurement in kcal

Secondary Outcome Measures

VAS scores for hunger and satiety [1 test day]
Visual analogue scale for hunger and satiety in mm (0-100 mm scale)
GI peptides [1 test day]
Measurement of GI peptide release during protein infusion (CCK, GLP-1, PYY, insulin and glucose)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Maastricht University Medical Center	Maastricht	Limburg	Netherlands	6003

Sponsors and Collaborators

Maastricht University Medical Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Maastricht University Medical Center

ClinicalTrials.gov Identifier:

NCT02500069

Other Study ID Numbers:

METC-14-3-006

First Posted:

Jul 16, 2015

Last Update Posted:

Jul 16, 2015

Last Verified:

Jul 1, 2015

Additional relevant MeSH terms:

Overweight

Hyperphagia

Caseins

Study Results

No Results Posted as of Jul 16, 2015