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OpenTrials
Completed

NCT Number: NCT03610477

MiCrobiome dieT Study

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.

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Key information

Conditions

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota

Minneapolis, Minnesota, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy adult over 18 years

Exclusion criteria

  • 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.

Treatment and study plan

Medium chain triglycerides

Dietary Supplement

Gel capsules, each containing 1 gram

Long chain triglycerides

Dietary Supplement

Gel capsules, each containing 1 gram

Primary outcomes

  1. Microbiome composition

    Time frame: Change from baseline daily for 17 days

    Species-level compositional assessment

  2. Dietary intake variation

    Time frame: Change from baseline daily for 17 days

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

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

  • General Mills

Registry information

Official study title

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

Acronym: MCTs

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Aug 1, 2018
Registry last updated
Nov 1, 2019

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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