Location Specific Differences in Intestinal Brake Activation

Obesity Clinical Trial

Official title:

The Effect of Intestinal Brake Activation at Different Locations in the Gut on Food Intake and Hormone Release

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02500069
• Other study ID #: METC-14-3-006
• Status: Completed
• Phase: N/A
• First received: March 18, 2014
• Last updated: July 14, 2015
• Start date: May 2014
• Est. completion date: March 2015

Study information

• Verified date: July 2015
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: March 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Ileal Brake
• Obesity
• Overeating
• Overweight
• Satiety

Intervention

Other:
• placebo
infusion of tap water in all regions (duodenum, jejunum and ileum)
• Casein (in duodenum)
infusion of protein in duodenum
• Casein (in jejunum)
infusion of protein in jejunum
• Casein (in ileum)
infusion of protein in ileum

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Center	Maastricht	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To measure ad libitum food intake at the end of the test day	Food intake measurement in kcal	1 test day	No
Secondary	VAS scores for hunger and satiety	Visual analogue scale for hunger and satiety in mm (0-100 mm scale)	1 test day	No
Secondary	GI peptides	Measurement of GI peptide release during protein infusion (CCK, GLP-1, PYY, insulin and glucose)	1 test day	No