A Phase 1/2 interventional study of NG bolus feeding over 5 min and Continuous NG feeding over 4 h in Enteral Feeding, Nasogastric Feeding and Diarrhoea, sponsored by University of Nottingham. Completed at 1 site in United Kingdom. Open to male participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-05-06.
Sponsored by University of Nottingham · Phase 1/2, Interventional, and Basic science
Following surgery some patients are unable to swallow. For those requiring nutritional support a tube is sometimes passed through the nose into the stomach to provide feeding. Traditionally this type of feeding is given slowly over the course of the day. However, it is thought that this mode of feeding might increase the amount of fluid entering the bowel contributing to symptoms of diarrhoea. An alternative strategy of feeding, given in larger volumes in a shorter space of time resembles normal feeding patterns and may reduce the amount of water entering the bowel.
In this study we want to use a non invasive medical imaging technique called "magnetic resonance imaging" (or MRI) to look at the volume of bowel water following these two feeding strategies in 12 healthy volunteers.
Each volunteer will have a tube inserted into the stomach via the nose and undergo the two feeding strategies at least 7 days apart. We will take repeated images using the MRI scanner to assess the bowel response and some samples of blood are required for analysis of blood sugar.
Experimental protocol and methods.
This is a single-centre, cross-over study involving 12 healthy volunteers. Two studies will be undertaken for each volunteer approximately 7 days apart:
The sequence of treatment allocations will be concealed to assessors until all interventions, data collection, and statistical analysis has been completed.
Subjects will be asked to arrive at 8:30 a.m. at the Sir Peter Mansfield Magnetic Resonance 1.5T, University of Nottingham, having abstained from alcohol, caffeine-containing drinks, and any medication for at least 24 h prior to the study, as well as having fasted overnight. An 80 cm 8FR Freka (Fresenius Kabi, Runcorn, UK) fine bore nasogastric (NG) tube will be inserted into the stomach via the nose as well as a cannula in the ante cubital fossa for blood sampling. The position of the NG tube will be verified by magnetic resonance imaging (MRI). Once the tube is sited, the volunteer will be asked to sit for 5 min in order to allow the tubes to settle and the body adapt to their presence. Following NG intubation subjects will undergo baseline MRI scanning and blood sampling for glucose, insulin and PYY. Feeding will commence at time 0. Scanning and blood tests will proceed at 30 min intervals for a total of 4 h. The feed used in all studies will be 400 ml of Resource® Energy Vanilla nutrient drink (Nestle Nutrition, Société des Produits Nestlé S.A), which is typical of a standard oral supplement.
In the TB study arm the supplement will be administered through the NG tube via syringes over 5 min; and in the TD study the feed will be administered using a pump at a rate of 100 ml/h for 4 h.
852 studies on the registry are indexed under Diarrhea; 78 are open to participants now.
This study's enrollment of 12 is below the median of 136 across 713 interventional studies indexed under Diarrhea.
Browse Diarrhea studies →University of Nottingham is the lead sponsor of 455 studies on the registry; 77 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Tube bolus (TB): feed administered via syringe through NG tube over 5 min.
Dietary Supplement: NG bolus feeding over 5 min
Continuous tube drip feeding (TD): feed pump delivered via the NG tube over 4 h.
Dietary Supplement: Continuous NG feeding over 4 h
Tube bolus (TB): 400 ml of Resource® Energy Vanilla nutrient drink, Societe des Produits Nestle S.A., administered via the NG tube over 5 min.
Also known as: Resource® Energy Vanilla nutrient drink, Societe des Produits Nestle S.A
Continuous tube drip feeding (TD): 400 ml of Resource® Energy Vanilla nutrient drink, Societe des Produits Nestle S.A., delivered via feeding pump through the NG tube over 4 h.
Also known as: Resource® Energy Vanilla nutrient drink, Societe des Produits Nestle S.A
Small bowel water volume (ml)
Small bowel water content assessed by magnetic resonance imaging.
Time frame: 0-240 min
Gastric emptying
Gastric volume assessed by magnetic resonance imaging.
Time frame: 0-240 min
Superior mesenteric artery blood flow
Superior mesenteric artery blood flow and velocity assessed by magnetic resonance imaging.
Time frame: 0-240 min
Peptide YY
Serum concentration of peptide YY
Time frame: 0-240 min
Insulin
Serum concentration of insulin
Time frame: 0-240 min
Glucose
Serum concentration of glucose
Time frame: 0-240 min
This study is completed, as verified in May 2013. You cannot join it, but the record below documents what was studied.
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University of Nottingham