MiCrobiome dieT Study

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Dietary Supplement: Medium chain triglycerides; Dietary Supplement: Long chain triglycerides

• Registration Number: NCT03610477
• Lead Sponsor: University of Minnesota

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-01
• Primary Completion: 2017-06-30
• Study Completion: 2017-12-30
• Study First Submitted: 2018-07-20
• Study First Submitted QC: 2018-07-31
• Study First Posted: 2018-08-01
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-30
• Last Update Posted: 2019-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

• Healthy adult over 18 years

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Medium Chain Triglyceride	Medium chain triglycerides	Participants will be randomized to consume 5% of total energy intake from medium chain triglycerides.
Long Chain Triglyceride	Long chain triglycerides	Participants will be randomized to consume 5% of total energy intake from long chain triglycerides.

Primary Outcome Measures

Name	Time	Method
Microbiome composition	Change from baseline daily for 17 days	Species-level compositional assessment
Dietary intake variation	Change from baseline daily for 17 days	Collected as 24-hour daily recalls assessed using novel methods for dietary pattern assessment

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States