Repetitive Brake Activation

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02511366
• Other study ID #: NL50301.068.14
• Status: Completed
• Phase: N/A
• First received: April 9, 2015
• Last updated: November 2, 2015
• Start date: January 2015
• Est. completion date: November 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Eating
• Ileal Brake
• Obesity

Intervention

Other:
• Ileal infusion of casein
Intraileal infusion of casein
• Ileal infusion of tap water
Intraileal infusion of tap water

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Center	Maastricht

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	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	No
Secondary	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	No
Secondary	Gastrointestinal peptide release (CCK)	Blood will be drawn during each test day (multiple time points) (4 in total, all within one week)	1 Day	No
Secondary	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	No
Secondary	Gastrointestinal peptide release (PYY)	Blood will be drawn during each test day (multiple time points) (4 in total, all within one week)	1 Day	No
Secondary	Gastrointestinal peptide release (insulin)	Blood will be drawn during each test day (multiple time points) (4 in total, all within one week)	1 Day	No
Secondary	Gastrointestinal peptide release (glucose)	Blood will be drawn during each test day (multiple time points) (4 in total, all within one week)	1 Day	No
Secondary	gastric emptying rate	Gastric emptying rate with 13C octanoic acid breath test to determine T1/2	1 Day	No
Secondary	Gallbladder volume	Gallbladder measurements with ultrasound (volume of GB in mL will be scored)	1 Day	No
Secondary	Small intestinal transit time	Small intestinal transit time measurements with H2 breath analyser and lactulose	1 Day	No