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临床试验/NCT06082726
NCT06082726已完成不适用

The Systemic Availability of Short-Chain Fatty Acids After Delivery in the Small Intestine and the Colon

KU Leuven1 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2023年10月9日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
KU Leuven
入组人数
13
试验地点
1
主要终点
Concentration of 13C-short-chain fatty acids in blood

研究概览

简要总结

The goal of this crossover study is to evaluate the systemic availability of short-chain fatty acids (SCFA) that are either administered in the small intestine or the colon in healthy volunteers. The main question it aims to answer is whether the site of administration affects the amount of SCFA that reaches the systemic circulation. On two test days participants will ingest capsules filled with SCFA that are specifically delivered in the small intestine or the colon. After ingestion, blood samples will be collected at regular time points.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • female and male
  • healthy participants
  • age within 18 - 50 years
  • normal BMI (18.5-25 kg/m^2)

排除标准

  • Chronic gastrointestinal disorders such as inflammatory bowel disease (IBD), irritable bowel syndrome (IBS), celiac disease, chronic constipation (less than 3 stools a week) and chronic frequent diarrhoea (more than 3 stools a day)
  • Previous abdominal surgery, except from appendectomy
  • Being on a weight loss, gluten-free, lactose-free, or vegan diet
  • The donation of blood during the last 3 months or suffering from low blood haemoglobin levels
  • The use of antibiotics or other medication that affects the gastrointestinal tract 3 months preceding the study and/or during the study
  • The use of prebiotics or probiotics 2 weeks preceding the study and/or during the study
  • Pregnancy, lactation or wish to become pregnant during the study period
  • Previous or current substance/alcohol dependence or abuse (> 2 units per day/14 units per week)

研究组 & 干预措施

small intestinal delivery capsules

Experimental

Participants will ingest small intestinal delivery capsules filled with short-chain fatty acids.

干预措施: SCFA (Dietary Supplement)

Colon-delivery capsules

Experimental

Participants will ingest colon-delivery capsules filled with short-chain fatty acids.

干预措施: SCFA (Dietary Supplement)

结局指标

主要结局

Concentration of 13C-short-chain fatty acids in blood

时间窗: up to 12 hours

Assessed by analysing SCFA in blood samples collected at regular time points

次要结局

未报告次要终点

研究者

发起方
KU Leuven
申办方类型
Other
责任方
Principal Investigator
主要研究者

Kristin Verbeke

Prof.

KU Leuven

研究点 (1)

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