|- candidate number||17642|
|- NTR Number||NTR4573|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||2-mei-2014|
|- Secondary IDs||14/06 METC number|
|- Public Title||MaagNeet|
|- Scientific Title||MaagNeet
Measuring gastric emptying times of different meals using MRI|
|- hypothesis||The primary objective of this study is to validate MRI as a functional measuring device for directly monitoring gastric emptying in vivo|
|- Healt Condition(s) or Problem(s) studied||Gastric emptying, MRI|
|- Inclusion criteria||• Age: 18-35 years |
• BMI: 18.5 – 25 kg/m2
• Healthy (as judged by the participant) (see form F1)
• Willing to comply with the study procedures
• Willing to be informed about incidental findings of pathology
• Having given written informed consent (see form E2)
• Having signed the MRI screening form (as mandated by the hospital, see form F2)
|- Exclusion criteria||• Failing to meet one or more of the inclusion criteria|
• Having difficulties with swallowing/eating
• Weight loss or weight gain of 5 kg or more during the last two months
• Having an endocrine or gastrointestinal disorder which may affect gastric emptying.
• Being allergic/intolerant for products under study (see form F1)
• Working at the Division of Human Nutrition (WUR)
• Current participation in other research from the Division of Human Nutrition (WUR)
|- mec approval received||yes|
|- multicenter trial||no|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||15-mei-2014|
|- planned closingdate||31-jul-2014|
|- Target number of participants||17|
|- Interventions||Shakes differing in viscosity and nutrient content|
|- Primary outcome||The main study parameter is stomach content as measured by MRI over a time of 2 hours.
|- Secondary outcome||The secondary outcome of the study is the difference in these measured parameters between the 4 treatments.
|- Timepoints||Intervals of 10 minutes|
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES|| Guido Camps|
|- CONTACT for SCIENTIFIC QUERIES|| Guido Camps|
|- Sponsor/Initiator ||Wageningen University (WUR)|
(Source(s) of Monetary or Material Support)
|EU FP 7 |
|- Brief summary||Rationale: After ingesting food, the bolus ends up in the stomach. The stomach has many functions, from secreting digestive fluids to kneading the contents and early absorption of small amounts of specific nutrients. The time food resides in the stomach is not only relevant for these processes, but also for the feeling of ‘being full’. Though there are indirect ways to measure the gastric emptying rate, better and more direct measuring techniques can yield better understanding and more accurate scientific research. Magnetic Resonance Imaging (MRI) offers the possibility to directly observe the process of gastric emptying.
Objective: The primary objective of this study is to validate MRI as a functional measuring device for directly monitoring gastric emptying in vivo.
Study design: In this study participants will drink 4 different liquid meals and a water control. The gastric filling and emptying by these loads will be measured by use of MRI. The order in which participants are exposed to the four different liquid meals is randomized and counterbalanced.
Study population: The study population consists of 20 apparently healthy, normal weight (BMI 20-25 kg/m2) men between 18 and 35 years old.
Main study parameter/endpoint: The main study parameter is gastric content (mL).
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The screening will consist of measurement of body height and weight and filling out several questionnaires (approx. 15 min) and an introductory Q&A session (approx. 15 min). If the participant’s initial questionnaire yields no objections and they are still interested after hearing the explanation of the study, they will be included in the study. For the study, participants will visit the MRI facility in Hospital Gelderse Vallei (Ede) four times (trial duration approx. 150 min). The subjects will scanned using MRI to measure their stomach volume before the treatment, and then be asked to drink one of the liquid meals. Questions will be asked about their hunger state and fullness. The study is non-therapeutic to the participants. The risk associated with participation is negligible (comparable with normal day to day activities).
|- Main changes (audit trail)|
|- RECORD||2-mei-2014 - 3-jun-2014|