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MiCrobiome dieT Study

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03610477
Acronym
MCTs
Enrollment
34
Registered
2018-08-01
Start date
2017-01-01
Completion date
2017-12-30
Last updated
2019-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Microbiome

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.

Interventions

DIETARY_SUPPLEMENTMedium chain triglycerides

Gel capsules, each containing 1 gram

DIETARY_SUPPLEMENTLong chain triglycerides

Gel capsules, each containing 1 gram

Sponsors

General Mills
CollaboratorINDUSTRY
University of Minnesota
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Microbiome compositionChange from baseline daily for 17 daysSpecies-level compositional assessment
Dietary intake variationChange from baseline daily for 17 daysCollected as 24-hour daily recalls assessed using novel methods for dietary pattern assessment

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026