Enteral Nutrition and Immune Proteins Study

Not Applicable

Active, not recruiting

• Conditions: Healthy Adults

• Registration Number: NCT06828094
• Lead Sponsor: University of Glasgow

Brief Summary

Eligible healthy adults who consent to take part in the study will be randomised to receive either a specialised milkshake for all of their normal daily diet (exculsive enteral nutrition, EEN) or the same specialised milkshake for half of their normal daily diet (partial enteral nutrition, PEN) for seven days. This randomisation is to prevent any bias. In the week before the allocated diet starts participants will be asked to give a weight and height measurement, blood sample, collect a stool and urine sample, and complete a food diary of everything they eat and drink using household measurements (e.g., a teaspoon) seven, four, and one day before the randomly allocated diet begins. Participants will also be asked to give a weight measurement, blood sample, and collect a stool and urine sample before they start the allocated diet. All participants will be asked to collect a third stool, urine, and blood sample and weight measurement at the end of the seven days dietary intervention. Blood samples collected during the study will be used to find out how the cells and proteins which instruct the immune system change during the special milkshake diet. Stool and urine samples will be used to measure the levels of different bacteria which naturally live inside the gut and how their behaviour might have changed during the diet. Those allocated to have PEN will be asked to complete a second set of food diaries for three days during your seven days of specialised milkshake.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-01
• Status Verified: 2025-02
• Study First Submitted: 2025-02-10
• Study First Submitted QC: 2025-02-13
• Last Update Submitted: 2025-02-13
• Study First Posted: 2025-02-14
• Last Update Posted: 2025-02-14
• Primary Completion: 2025-11-21
• Study Completion: 2025-11-21

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

• Healthy adults (>/= 18 years)

Exclusion Criteria

• Those sufferring from acute or chronic illness (defined as illness which requires regular visits to health services)
• Those who have experienced weight changes +/- 2kg in the past month.
• Previous gut surgery,
• Use of antibiotics or steroids in the past month
• Food allergies which prevent consumption of the enteral nutrition used (milk protein allergy)
• Current pregnancy or breastfeeding.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Changes in Inflammation-Related Proteins	Seven days	The main outcome measure of this study is to determine changes in inflammation-related proteins in the peripheral blood in response to the seven day dietary intervention.

Secondary Outcome Measures

Name	Time	Method
Changes in Immune Cell Populations	Seven days	One of the secondary outcome measures is to explore changes in immune cell popultions within the peripheral blood in response to the seven day dietary intervention.
Changes in Gut Microbiome Composition	Seven days	One of the secondary outcome measures is to explore changes in composition of the gut microbiome in response to the seven day dietary intervention.

Trial Locations

Locations (1)

University of Glasgow; 🇬🇧 Glasgow, United Kingdom