跳至主要内容
临床试验/NCT03610477
NCT03610477已完成不适用

Effect of Normal Dietary Intake and Medium Chain Triglycerides Supplementation on the Human Microbiome

University of Minnesota1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2017年1月1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
入组人数
34
试验地点
1
主要终点
Microbiome composition

研究概览

简要总结

The human gut microbiome is the community of bacteria that reside within the human intestine. These microbes are constantly exposed to the end-products and partial break-down-products of digestion from the foods consumed each day. Very little is known about the complex interaction of specific dietary components with the microbiome over time in one individual. In order to produce robust analysis of these interactions, longitudinal samples with detailed dietary intake information from healthy human subjects are needed.

The complex relationship between dietary intake and the microbiome, and the potential health implications of human exposure to microbial metabolites, are only beginning to be understood. It is well known that altered dietary intake can trigger rapid, although transient, changes in the composition of the microbiome in as little as 1 to 2 days. The biggest factors in determining microbial response to diet are thought to include an individual's starting microbiome, long-term dietary habits, and environmental exposures.

It is not well understood how small dietary differences from day-to-day impact the microbiome. A longitudinal dataset with accurately recorded dietary data and multiple samples over 17 days will provide valuable insight into the changes that occur at the individual level over time, while controlling for dietary trends and initial microbiome composition.

Medium chain triglycerides (MCTs) have systemic beneficial effects and increase survival in rats by preventing gut injury and permeability following lipopolysaccharide administration, preventing alcohol-induced liver injury, and protecting against the development of colitis in a model of Crohn's disease. Understanding the interaction of MCTs with the microbiome in humans could lead to important advancements in the understanding of how diet impacts the microbiome composition, and ultimately, human health. This proposed study is designed to evaluate the effect of MCTs compared with long chain triglycerides on the normal structure of the microbiome and data will not be used to diagnose, prevent, cure or treat disease.

The purpose of this study is to: 1) investigate the role daily dietary variation plays in microbiome composition and stability, and 2) explore the effect of MCT supplementation on microbiome composition in healthy adults.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy adult over 18 years

排除标准

  • Type 1 diabetes mellitus or insulin dependent type II diabetes mellitus
  • Individuals currently maintaining a ketogenic diet
  • Women who are currently pregnant or breast feeding
  • Use of antibiotics in the last 3 months
  • Self-reported pre-existing history of liver disease e.g. cirrhosis or diagnosed fatty liver disease.

研究组 & 干预措施

Long Chain Triglyceride

Placebo Comparator

Participants will be randomized to consume 5% of total energy intake from long chain triglycerides.

干预措施: Long chain triglycerides (Dietary Supplement)

Medium Chain Triglyceride

Active Comparator

Participants will be randomized to consume 5% of total energy intake from medium chain triglycerides.

干预措施: Medium chain triglycerides (Dietary Supplement)

结局指标

主要结局

Microbiome composition

时间窗: Change from baseline daily for 17 days

Species-level compositional assessment

Dietary intake variation

时间窗: Change from baseline daily for 17 days

Collected as 24-hour daily recalls assessed using novel methods for dietary pattern assessment

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验