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Active, Not Recruiting

NCT Number: NCT06828094

Enteral Nutrition and Immune Proteins Study

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Glasgow

Glasgow, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. 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

  1. Changes in Immune Cell Populations

    Time frame: 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.

  2. Changes in Gut Microbiome Composition

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Glasgow

Other

Registry information

Official study title

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

Acronym: ENIP

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Feb 14, 2025
Registry last updated
Feb 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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