Testing Impact of food composition on Gastric Emptying Rate
- Conditions
- normale processen van vertering en absorptiegastric emptying
- Registration Number
- NL-OMON42534
- Lead Sponsor
- IZO food research B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 10
• Age 18-35 years
• Use of 3 meals per day
• Voluntary participation (signed informed consent)
• Willing to comply with study procedures
• Accept disclosure of the financial benefit of participation in the study to the authorities concerned
- Accept reporting of abnormal blood glucose values to volunteer or his/her physician
• Smoking
• Current or previous underlying disease of the GI tract, liver, bile bladder, thyroid gland (self-reported)
• Allergy to ingredients in the test products.
• Use of antacids or laxatives (up till 1 month prior to inclusion)
• Pregnancy and lactation
• Vegetarians or vegans
• Drug use
• Personnel of NIZO food research, their partner and their first and second degree relatives
• Participation in any clinical trial up to 30 days before Day 01 of this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Gastric emptying rate, based on 13CO2/12CO2 ratio in expired breath for up to 3<br /><br>hours after meal consumption, and expressed as half-emptying time and lag<br /><br>phase.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Other gastric emptying parameters:<br /><br>Gastric Emptying Coefficient<br /><br>Percentage Dose Recovery (PDR)<br /><br>Cumulative PDR<br /><br><br /><br>Glucose concentration in finger prick blood</p><br>