Enteral Nutrition and Immune Proteins Study (ENIP)

The Effect of Exclusive and Partial Enteral Nutrition on Inflammation-related Proteins and on the Gut Microbiome of Healthy Adults

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Healthy Adults
• Intervention / Treatment: Dietary supplement: enteral nutrition

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Glasgow, United Kingdom
    • University of Glasgow

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exclusive Enteral Nutrition; Replacement of 100% of a participants daily energy intake with enteral nutrition for seven days	Dietary supplement: enteral nutrition; Nutritionally complete liquid diet used in the study to replace all (exclusive enteral nutrition) or half (partial enteral nutrition) of a participants daily energy intake
Experimental: Partial Enteral Nutrition; Replacement of 50% of a participants daily energy intake with enteral nutrition for seven days	Dietary supplement: enteral nutrition; Nutritionally complete liquid diet used in the study to replace all (exclusive enteral nutrition) or half (partial enteral nutrition) of a participants daily energy intake

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Inflammation-Related Proteins	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.	Seven days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Immune Cell Populations	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.	Seven days
Changes in Gut Microbiome Composition	One of the secondary outcome measures is to explore changes in composition of the gut microbiome in response to the seven day dietary intervention.	Seven days

Collaborators and Investigators

• Sponsor: University of Glasgow

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Estimated): November 21, 2025
• Study Completion (Estimated): November 21, 2025

Study Registration Dates

• First Submitted: February 10, 2025
• First Submitted That Met QC Criteria: February 13, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 13, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 200220086

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No