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临床试验/NCT06828094
NCT06828094进行中(未招募)不适用

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

University of Glasgow1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2023年3月1日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
38
试验地点
1
主要终点
Changes in Inflammation-Related Proteins

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy adults (>/= 18 years)

排除标准

  • 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.

结局指标

主要结局

Changes in Inflammation-Related Proteins

时间窗: 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.

次要结局

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

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Bernadette White

Miss

University of Glasgow

研究点 (1)

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