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

NCT04113200 | Completed

• 1 other identifier: RGS129061
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Small bowel water response to feeding

  Area under the curve for small bowel water measured by MRI over four hours from baseline.

  After four hours from baseline

Secondary Outcomes (14)

• Gastric volume relative to baseline

  After four hours from baseline

• Mean post feeding gastric emptying rate

  Over four hours from baseline.

• Superior mesenteric blood flow

  Over four hours from baseline.

• Incremental area under the curve for arterialised whole blood glucose

  Over four hours post baseline

• Incremental area under the curve for insulin

  Over four hours from baseline

Study Arms (2)

F+ALG

EXPERIMENTAL

An alginate containing feed: MerMed One (Kaneka Corporation). 300mls administered nasogastrically over one hour.

Dietary Supplement: MerMed One

F-ALG

OTHER

A standard enteral feed commonly used in practice. Nutricomp Soy Fibre (B.Braun). 300mls administered nasogastrically over one hour.

Dietary Supplement: Nutricomp Soy Fibre

Interventions

MerMed One DIETARY_SUPPLEMENT

A 1 kcal per ml enteral feed containing an alginate.

F+ALG

Nutricomp Soy Fibre DIETARY_SUPPLEMENT

A 1kcal per ml enteral feed not containing alginate.

F-ALG

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Non- smoking (non- vaping) males
• aged 18- 45 years
• body mass index (BMI) of 18.5-24.5kg/ m2 or a BMI of 24.5- 26kg/ m2
• a waist circumference of less than 94 cm.
• ability to give informed consent

You may not qualify if:

• A history of an acute illness, lasting more than a week, in the last six weeks;
• taking any medications for gastrointestinal disorders, including acid suppressants or anti-spasmodics,
• taking anti-depressants or symptoms of clinical depression (defined by a score \>10 on the Beck Depression Inventory)
• taking medication for diabetes or having diabetes
• a history of substance abuse in the last six months;
• having any factors that preclude safe MRI;
• a history of gastrointestinal disorders, including Gastro Oesophgeal Reflux Disease, Irritable Bowel Syndrome, active peptic ulcer disease; having diabetes;
• previous surgery to the gastrointestinal or biliary systems;
• having characteristics of those with an eating disorders (defined by a score of more than 20 on the Eating Attitudes Test (EAT-26));
• having an allergy or intolerance to the ingredients in the enteral feeds, or the cheese and tomato pasta meal

Sponsors & Collaborators

• University of Nottingham: lead
• Kaneka Corporation: collaborator

Study Sites (1)

The University of Nottingham

Nottingham, Nottinghamshire, NG7 2RD, United Kingdom

Location

Study Officials

• Moira Taylor, PhD

  University of Nottingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: On each study day, when the feed is administered, the Principle investigator (if present) and the research nurse administering the feed and obtaining blood samples are aware of which enteral feed will be given, but the MRI (magnetic resonance imaging) scanner, and researcher collecting outcome data will not be.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants will receive the control and intervention product according to randomised crossover design with a minimum washout period of 7 days.

Study Record Dates

• First Submitted: July 11, 2019
• First Posted: October 2, 2019
• Study Start: January 29, 2019
• Primary Completion: March 30, 2020
• Study Completion: March 30, 2020
• Last Updated: September 23, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: When requested.
• Access Criteria: On receipt of requests, data will be made accessible if agreed by both the University of Nottingham and Kaneka Corporation.

Locations

GB (1)