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临床试验/NCT06686888
NCT06686888已完成不适用

The Impact of Short-Chain Fatty Acids on the Gut Hormone Release After Delivery in the Small Intestine and Colon

KU Leuven1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2024年9月25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
28
试验地点
1
主要终点
The release of gut hormones

研究概览

简要总结

The goal of this crossover study is to evaluate the impact of short-chain fatty acids (SCFA) on the gut hormone release after administration in the small intestine or colon in healthy participants. The main question it aims to answer is whether the site of administration of SCFA affects the gut hormone release. On test days participants will ingest capsules filled with SCFA that are specifically delivered in the small intestine or the colon. Subsequently, blood samples are 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

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

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

Colon-delivery capsules

Experimental

SCFA

干预措施: SCFA (Dietary Supplement)

Small intestinal delivery capsules

Experimental

SCFA

干预措施: SCFA (Dietary Supplement)

placebo capsules

Placebo Comparator

Microcristalline cellulose

干预措施: microcristalline cellulose (Dietary Supplement)

结局指标

主要结局

The release of gut hormones

时间窗: 8 hours

Gut hormone GLP-1 (pmol/l) and PYY (pg/ml) concentrations will be quantified in the blood samples collected at different time points.

次要结局

  • The glycemic and insulinemic response(8 hours)

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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