The effect of repetitive ileal brake activation on food intake, satiety, gastrointestinal peptide release, gastric emptying and gallbladder volume

• Conditions: obesity; satiety; 10003018

• Registration Number: NL-OMON40999
• Lead Sponsor: niversiteit Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 40

Inclusion 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 oral contraceptives.
• BMI between 18 and 25 kg/m2)
• Weight stable over at least the last 6 months

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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Difference in ad libitum meal intake (as measured during ad libitum pasta meal)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Difference in satiation (as measured by VAS) per time point<br /><br>Measurements in plasma of the gut hormones CCK, GLP-1, PYY, insulin and glucose<br /><br>Difference in gastric emptying<br /><br>Difference in duodenocaecal transit time<br /><br>Difference in galbladder volume</p><br>