Enteral Nutrition and Immune Proteins Study

NCT ID: NCT06828094

Last Updated: 2025-02-14

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2025-11-21

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Exclusive Enteral Nutrition

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

Group Type: EXPERIMENTAL

enteral nutrition

Intervention Type: 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

Partial Enteral Nutrition

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

Group Type: EXPERIMENTAL

enteral nutrition

Intervention Type: 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

Interventions

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Glasgow

OTHER

Sponsor Role: lead

Responsible Party

Bernadette White

Miss

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Glasgow

Glasgow, , United Kingdom

Countries

United Kingdom

Other Identifiers

200220086

Identifier Type: -

Identifier Source: org_study_id