Influence of carbonic acid/CO2 on gastric emptying and intragastric mixing of chyme
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - Ethnic origin: Caucasian - BMI: > 18 kg/m² and < 27 kg/m² - Minimum weight: 50 kg - Good health assessed by the investigator as not deviating from the norm in clinical terms - Complete immunization against SARS-Cov2 (vaccinated or recovered). - Presence of written informed consent.
Exclusion criteria
Exclusion criteria: - disorders/diseases affecting the swallowing process (e.g., severe dysphagia related to food and/or solid oral dosage forms). - gastrointestinal disorders and/or pathologic changes that may interfere with gastric emptying - known or suspected stenosis, fistula, or mechanical obstruction within the gastrointestinal tract - surgical procedures on the gastrointestinal tract within the past 12 months - inflammatory bowel disease (Crohn's disease, ulcerative colitis, or diverticulitis) - Individuals who are unable to consume an appropriately sized portion of a meal in a given amount of time - Alcohol or drug addiction - Smokers with a cigarette consumption of more than 10 cigarettes per day - heavy tea or coffee drinkers (more than 1 L per day) - Eating disorders such as anorexia, bulimia - positive pregnancy test or gravidity - positive SARS-Cov 2 antigen rapid test or PCR test - Individuals known to be unwilling or unable to reliably follow instructions - Individuals who are unable to understand written and verbal instructions and teachings regarding the study risks they face - less than 14 days after acute illness - Systemic use of medications, especially those that affect gastrointestinal tract function - Known allergies or intolerances to standard meal components - Known hypersensitivity to caffeine or foods containing caffeine - Intolerance to lactose
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Concentration of caffeine in saliva | — |
Secondary
| Measure | Time frame |
|---|---|
| cmax, tmax, AUC(0-120), AUC(0-360) | — |
Countries
Germany
Contacts
Institut für Pharmazie - Biopharmazie & Pharmazeutische Technologie