Comparison of an Alginate Containing Enteral Feed and an Alginate Free Enteral Feed.

NCT04113200 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2022-09-23

No results posted yet for this study

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

Conditions

  • Enteral Nutrition

Interventions

DIETARY_SUPPLEMENT

MerMed One

A 1 kcal per ml enteral feed containing an alginate.

DIETARY_SUPPLEMENT

Nutricomp Soy Fibre

A 1kcal per ml enteral feed not containing alginate.

Sponsors & Collaborators

  • Kaneka Corporation

    collaborator INDUSTRY
  • University of Nottingham

    lead OTHER

Principal Investigators

  • Moira Taylor, PhD · University of Nottingham

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-01-29
Primary Completion
2020-03-30
Completion
2020-03-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04113200 on ClinicalTrials.gov