Location Specific Differences in Intestinal Brake Activation

Not Applicable

Completed

• Conditions: Ileal Brake; Overweight; Satiety; Obesity; Overeating
• Interventions: Other: Casein (in duodenum); Other: Casein (in jejunum); Other: Casein (in ileum); Other: placebo

• Registration Number: NCT02500069
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-03-18
• Study Start: 2014-05
• Primary Completion: 2014-12
• Study Completion: 2015-03
• Status Verified: 2015-07
• Study First Submitted QC: 2015-07-14
• Last Update Submitted: 2015-07-14
• Study First Posted: 2015-07-16
• Last Update Posted: 2015-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Duodenum	Casein (in duodenum)	Infusion of casein in duodenum
Jejunum	Casein (in jejunum)	Infusion of casein in jejunum
Ileum	Casein (in ileum)	Infusion of casein in ileum
Placebo	placebo	Tap water infusion in all three locations (duodenum, jejunum and ileum)

Primary Outcome Measures

Name	Time	Method
To measure ad libitum food intake at the end of the test day	1 test day	Food intake measurement in kcal

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Maastricht University Medical Center; 🇳🇱 Maastricht, Limburg, Netherlands