Status:
COMPLETED
Comparison of an Alginate Containing Enteral Feed and an Alginate Free Enteral Feed.
Lead Sponsor:
University of Nottingham
Collaborating Sponsors:
Kaneka Corporation
Conditions:
Enteral Nutrition
Eligibility:
MALE
18-45 years
Phase:
NA
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 com...
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 collect...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
January 29 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 30 2020
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04113200
Start Date
January 29 2019
End Date
March 30 2020
Last Update
September 23 2022
Active Locations (1)
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1
The University of Nottingham
Nottingham, Nottinghamshire, United Kingdom, NG7 2RD