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MiCrobiome dieT Study (MCTs)

University of Minnesota (UMN) logo

University of Minnesota (UMN)

Status

Completed

Conditions

Healthy

Treatments

Dietary Supplement: Medium chain triglycerides
Dietary Supplement: Long chain triglycerides

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT03610477
1610M95982

Details and patient eligibility

About

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.

Enrollment

34 patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

34 participants in 2 patient groups, including a placebo group

Medium Chain Triglyceride
Active Comparator group
Description:
Participants will be randomized to consume 5% of total energy intake from medium chain triglycerides.
Treatment:
Dietary Supplement: Medium chain triglycerides
Long Chain Triglyceride
Placebo Comparator group
Description:
Participants will be randomized to consume 5% of total energy intake from long chain triglycerides.
Treatment:
Dietary Supplement: Long chain triglycerides

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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