Enteral Nutrition and Immune Proteins Study

NCT06828094 | Active Not Recruiting

• 1 other identifier: 200220086
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Adults

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Changes in Immune Cell Populations

  Seven days

• Changes in Gut Microbiome Composition

  Seven days

Study Arms (2)

Exclusive Enteral Nutrition

EXPERIMENTAL

Replacement of 100% of a participants daily energy intake with enteral nutrition for seven days

Dietary Supplement: enteral nutrition

Partial Enteral Nutrition

EXPERIMENTAL

Replacement of 50% of a participants daily energy intake with enteral nutrition for seven days

Dietary Supplement: enteral nutrition

Interventions

enteral nutrition DIETARY_SUPPLEMENT

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

Exclusive Enteral Nutrition; Partial Enteral Nutrition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy adults (\>/= 18 years)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Glasgow: lead

Study Sites (1)

University of Glasgow

Glasgow, United Kingdom

Location

MeSH Terms

Interventions

Enteral Nutrition

Intervention Hierarchy (Ancestors)

Feeding Methods; Therapeutics; Nutritional Support; Nutrition Therapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Miss

Study Record Dates

• First Submitted: February 10, 2025
• First Posted: February 14, 2025
• Study Start: March 1, 2023
• Primary Completion: November 21, 2025
• Study Completion: November 21, 2025
• Last Updated: February 14, 2025

Record last verified: 2025-02

Locations

GB (1)