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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON40999
Enrollment
40
Registered
2014-10-23
Start date
2014-10-01
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

obesity satiety

Interventions

Infusing casein into the ileum

Sponsors

Universiteit Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Difference in ad libitum meal intake (as measured during ad libitum pasta meal)

Secondary

MeasureTime frame
Difference in satiation (as measured by VAS) per time point Measurements in plasma of the gut hormones CCK, GLP-1, PYY, insulin and glucose Difference in gastric emptying Difference in duodenocaecal transit time Difference in galbladder volume

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)