Comparison of an Alginate Containing Enteral Feed and an Alginate Free Enteral Feed.
Condition: Enteral Nutrition
Study type: Interventional

Summary: 
      When patients cannot eat and drink enough a tube can be placed through their nostril, down
      the back of their throat into their stomach and used to give their nutrition as a liquid
      feed. One of the commonest problems when using this tube is regurgitation of feed up from the
      stomach (gastro- oesophageal reflux (GOR)), or liquid stools (diarrhoea). This can cause the
      patient discomfort, a higher risk of getting a skin or chest infection, and increase the risk
      that the feed is stopped.

      The investigators intend to investigate, in twelve healthy young men, whether adding a form
      of dietary fibre (alginate) to the feed could reduce these symptoms (diarrhoea and GOR),
      hence ensuring patients are properly nourished and recover as quickly as possible from their
      illness, Each volunteer will come to the lab twice and will have a tube inserted into the
      stomach via the nose so that they can be given both feeds. Each time, the investigators will
      take repeated pictures of how the feed is passing through their gut using a non invasive
      technique called 'magnetic resonance imaging' (MRI), take blood samples to see how quickly
      the nutrition is absorbed into the blood, and measure how hungry they feel
    

Detailed description: 
      TRIAL / STUDY DESIGN Each participant will be required to attend a screening visit, a brief
      education visit re collecting dietary information, adhering to a standardised diet and faecal
      sample collection; two, approximately five hour, study visits with 7- 10 days between each
      visit; and a brief visit after each intervention day to return diet information and the
      faecal samples. Prior to the study visits they will be required to consume a standardised
      diet for four days, based on their usual intake with similar macronutrient composition to the
      feed. On each study visit they will be fed, via a nasogastric enteral tube, 300mls/ hour of
      one of two enteral feeds (total feed delivered 300mls). The gastric response will be measured
      using MRI scanning, the biochemical and endocrine response will be measured using
      arterialised venous blood samples, and the appetitive response will be measured using visual
      analogue scales, and direct measurement of food intake at an ad libitum test meal.
      Participants will continue to consume a standardised diet for 3 days after the delivery of
      the enteral feed. Faecal samples will be collected before and after the visit day, for pH
      measurement.

      Ethical approval has been obtained from the Faculty of Medicine and Health Sciences Ethics
      Committee, University of Nottingham. All participants will provided informed, written
      consent.
    

Intervention name(s): MerMed One; Nutricomp Soy Fibre
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): A 1 kcal per ml enteral feed containing an alginate.; A 1kcal per ml enteral feed not containing alginate.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Participants will receive the control and intervention product according to randomised crossover design with a minimum washout period of 7 days.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science