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Clinical Trials/NCT06828094
NCT06828094Active, not recruitingNot Applicable

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

University of Glasgow1 site in 1 country38 target enrollmentStarted: March 1, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
38
Locations
1
Primary Endpoint
Changes in Inflammation-Related Proteins

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Arms & Interventions

Exclusive Enteral Nutrition

Experimental

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

Intervention: enteral nutrition (Dietary Supplement)

Partial Enteral Nutrition

Experimental

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

Intervention: enteral nutrition (Dietary Supplement)

Outcomes

Primary Outcomes

Changes in Inflammation-Related Proteins

Time Frame: 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 Outcomes

  • Changes in Gut Microbiome Composition(Seven days)
  • Changes in Immune Cell Populations(Seven days)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Bernadette White

Miss

University of Glasgow

Study Sites (1)

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