The DINE-Normal proof of concept study
Research type
Research Study
Full title
Does Intermittent Nutrition Enterally Normalise hormonal and metabolic responses to feeding in critically ill adults? The DINE-Normal proof of concept study.
IRAS ID
328469
Contact name
Matt Thomas
Contact email
Sponsor organisation
North Bristol NHS Trust
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Everyone needs food but many people, especially those who are ill, can’t eat enough and are malnourished. Malnourished patients suffer more complications and are less likely to survive. When patients are at risk of malnutrition, we put a tube through their nose into their stomach (nasogastric or NG tube). We give liquid food through the tube, hour after hour, day and night – this is continuous feeding. The idea is to correct harmful effects of malnutrition.
This is a very abnormal way to provide feed. It has unpleasant side effects like nausea, diarrhoea and insomnia. It may not give enough calories. It also changes the way the body uses the food. This could mean it doesn’t correct malnutrition and may even make things worse.
Humans naturally eat meals in daytime and fast at night – this is intermittent feeding. Our team and others have compelling evidence this pattern is beneficial in volunteers. Intermittent feeding maintains normal function of vital metabolic processes and the correct pattern of vital behaviours like sleep. It may improve cell repair and immunity and reduce inflammation.
There is a need to establish whether this is also true for patients in ICU. Patients in ICU are at high risk of malnutrition and have NG feed routinely. They have abnormal metabolism, disrupted sleep, reduced immunity and increased inflammation. Intermittent feeding might improve all this, leading to better outcomes.
This study is the first step. Thirty suitable patients will be allocated by chance (randomised) to intermittent or continuous feed for 48 hours. The responses will be assessed clinically (calories delivered) and with laboratory tests (like blood insulin levels). If patients in ICU can be fed enough intermittently and show a more normal metabolic response we will do a larger study with patient centred outcomes.
REC name
Wales REC 3
REC reference
23/WA/0297
Date of REC Opinion
17 Oct 2023
REC opinion
Favourable Opinion